Aston Life Sciences

Aston Life Sciences offers Consulting and Recruitment services for its clients in the Life Sciences Industries like Pharma, Biotech, Medical Devices, Cosmetic, Diagnostic, Drug Delivery Devices, and others. The firm is usually involved in consulting projects like Engineering, Quality Assurance, Regulatory Affairs, Clinical Trials, GxP information systems, and more.

ATP-CGPharm Group

The ATP-CGPharm Group is a consultancy that helps to support the improvement of the manufacturing processes and quality programs to ensure medical product quality, patient safety, and strict compliance with regulatory requirements. The company offers a broad range of services in GxP Engineering, Commissioning, Qualification & Validation, Quality Assurance, Quality Control, and Environmental Monitoring.

MHHC

MHHC is a Pharmaceutical consulting company that provides a full range of services for Pharmaceutical or Biotech companies planning to expand their operations into Switzerland. The firm’s service offering includes the core aspects of pharmaceutical or biotech subsidiary establishment in Switzerland – financial and legal set-up, medicinal product approvals, and required pharmaceutical licenses.

InsideReg

InsideReg is a small Regulatory Affairs Consultancy specializing in Chemistry, Manufacturing, and Controls (CMC) and Regulatory strategy. The firm works with companies of all sizes: from start-ups to top ten pharma, and at all stages of product development: from proof of concept to post-marketing activities.

Maxia Strategies

Maxia Strategies is a Life Sciences Regulatory consultancy. The firm specializes in creating efficient product development strategies and providing supporting regulatory services. Maxia Strategies helps small to medium-sized enterprises maximize the value of their products throughout their development lifecycle.

ObelysQ

ObelysQ is a dynamic consulting company providing high-level expertise and innovative tailored solutions to the Pharmaceutical industry to optimize the execution of Clinical Trials. The firm offers services like GCP consulting, GCP and GVP auditing, SOP Development, Health Authority inspections, Training and Gap Analysis.

Intilaris LifeSciences

Intilaris is a consulting and services company focused on helping Pharma companies to foster innovation, improve productivity and performance, and develop effective business strategies. The company delivers expertise across Strategy, Consulting, Digital, Technology, and Operations and specialize in areas like Project Management, Risk Management, Quality Management, Clinical Trial Management, Validation, and more.

PharmInsight

PharmInsight is specializing in business development and portfolio optimization for companies in Life Sciences. Its clients are in Pharmaceutical, Biotech, Medical Devices, Diagnostics, R&D industries from across the globe. PharmInsight has experience in Portfolio optimization, Out-licensing and partnering Services, In-licensing services, Strategy Consulting, and Market Access Services.

Phact

Phact is a Swiss-based company and operates worldwide and specializes in supporting companies in different areas of Drug Regulatory Affairs. The company provides support in the fields of Quality, Quality Management, GMP, Regulatory Affairs, and Training. Its customers come from all over the world and from all sectors of the Pharmaceutical and Biotech industry.

GXP CONSULTING

GXP CONSULTING is a consulting company specialized in Life Sciences which provides high-quality support to its customers through a full range of services throughout the whole product lifecycle. The firm specializes in areas like Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence, Engineering, Manufacturing and Maintenance, and Project Management.

Avanti Europe

Avanti Europe is a specialist consultancy and knowledge management company. The company provides expert support and offers solutions during the entire product lifecycle in highly regulated industrial areas including Medical Devices, Pharmaceuticals, and more. The firm provides services within Design & Development, Project Management, Quality Assurance, Regulatory Affairs, Risk Management, and Process Management.

Beyond Conception

Beyond Conception is a specialized consulting firm in the Life Sciences industry, with a focus on medical devices, packaging technologies, and information security. The company works with global organizations to design and implement cross-divisional strategic and regulatory compliance projects (EU MDR, FMD, UDI) for medical devices, product security/anti-counterfeiting, and information security.

Carag

Carag offers specialized engineering and Medical Device consulting services that provide its clients with advantages in their markets without taking center stage itself. The broad range of services starts with technical feasibility checks and continues with product development through marketing approvals, regardless of the regulatory complexity.

Axxos

Axxos is a consulting company with an overall experience of more than 125 years in the Medical Device field and has collected extensive and profound expertise. Company’s main area of expertise Quality Management and can support its clients in areas like Quality Management ISO 13485, FDA Services, Clinical Evaluation, and Validation.

The Tao of Excellence

The Tao of Excellence is a team of experts that provide hands-on support and specialist services for Medical Device manufacturers. The firm assists clients within areas like Regulatory Strategy, Compliance, Audit readiness, Certification, and Quality Management System related topics.

Trinzo

Trinzo is a consultancy that works with Medical Device companies to help solve their quality and regulatory compliance challenges. The firm applies a personalized approach to the customer’s needs and provides a wide range of services, including, Quality and Regulatory Compliance & Remediation, Project Management, Lean Quality Systems, Interim Leadership, and Talent Acquisition.

Congenius

Congenius offers smart Medical Device consultancy services in the fields of Quality, Regulatory, eHealth, Clinical, and Operations. The company provides tailored expertise and leadership to global firms, established SME’s, as well as aspiring start-ups in the medical device, in-vitro diagnostics, and pharmaceutical industry.

QUNIQUE

QUNIQUE is a consulting company that provides Medical Device companies with customized solutions for Quality Management Systems (QMS), supporting the implementation of new processes and training personnel appropriately. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with the regulations.

GMB Services

GMB Services is a multi-disciplinary consulting company providing solutions for complex Medical Devices. 
GMB Services can assist companies within specific or all PLM phases. Moreover, the firm provides services within areas like Regulatory Affairs and Quality Assurance consulting services (CE marking, FDA submission, QMS).

Meditec Consulting

Meditec Consulting is a firm that specializes in Regulatory and Quality Consulting services throughout the product life-cycle to help manufacturers comply with these regulatory requirements. Firms consultants have many years of experience with different regulations in various countries for medical devices, In-vitro Diagnostics, Combination Products, Pharmaceuticals, and Biologics.

Michor Consulting

From conception and strategy to post-market maintenance – Michor Consulting offers advice and training in all key areas of regulatory affairs, compliance, business organization, quality assurance, and risk and interim management.

BioMedConsult

BioMedConsult was founded in 2006 as an independent consulting company which offers their international clients a comprehensive & high level of expertise in Life Science. 

H.M. Pharma Consultancy

H.M. Pharma Consultancy is an information-driven knowledge foundry in the service of pharmaceutical and medical device business development.

Pharmaceutical and Regulatory Services GmbH

PRSG is a company that offers comprehensive services for all aspects of regulatory affairs in means of a One-Stop-Shop. They can help you identify the ideal strategic and regulatory marketability approach for your pharmaceutical product.

RD&C – Research, Development & Consulting

RD&C provides expertise and consulting for R&D projects in Life Sciences from early research to market authorization. They design, plan and manage such projects with sound expertise to guarantee optimum results and revenues.

Drehm Pharma

Drehm Pharma offers a broad range of consultancy services to pharmaceutical companies of all sizes. They support successful product lifecycle management, ranging from the conception of a product idea through strategic planning, development, testing, registration, marketing, and quality management. 

Anapur AG

Over many years, Anapur has built significant know-how in the area of validation and qualification of pharmaceutical systems. They offer solutions tailored to meet your demands for reaching GMP compliance.

Acet Pharma

Acet Pharma is a consulting company founded in 2016 by Udo Tschernuter. Acet Pharma offers support and assistance in all pharmaceutical-technical areas such as product development, manufacturing, storage, transport, quality-control, quality-assurance, regulatory documents.

Vela Laboratories

VelaLabs is a world-wide acting, GMP-certified contract laboratory that offers in-depth analytical characterization services for proteins and provides consultancy services.

PSR Orphan Experts

PSR is a full-service Orphan Drug CRO, it provides Biopharmaceutical companies with a variety of services that allow end-to-end solutions spanning the whole Orphan drug development cycle. The firm can support clients with an integrated approach from Regulatory Strategy through to conducting the necessary Clinical Studies in all development phases.

DADA Consultancy

DADA Consultancy is one of the leading independent consulting agencies for Regulatory Affairs in Europe, the firm offers a full range of high quality and tailored regulatory and pharmacovigilance services for human and veterinary products. DADA Consultancy has a team of experts is highly trained Chemical, Pharmaceutical, and Biomedical professionals, supported by a wide network of external scientific experts.

Zwiers Regulatory Consultancy

Zwiers Regulatory Consultancy provides full regulatory support for Medical Device and Pharmaceutical companies, throughout the entire product lifecycle. From initial clinical trial application to post-marketing compliance. The consulting firm’s services include Regulatory Strategic Advice, Medical Writing, Regulatory Intelligence, and Training.

BMclinical

BMclinical offers a unique approach to clinical trial supply and aims to simplify the Pharmaceutical companies’ supply chain whilst providing the highest level of service and patient safety. Through experience and collaboration, the company offers services like Commercial Drug Sourcing, Supply Management, and Global Distribution.

CURARE

CURARE is a consultancy firm that specializes in designing strategies for early clinical drug development programs. The firm has a team of experts that have a strong drive and a pragmatic approach to make each project successful within the budget and time constraints given. CURARE’s main areas of expertise are Strategic Clinical Drug Development, Clinical Pharmacology, and Clinical Regulatory support.

Occams

Occams provides strategic services to companies in the Pharmaceutical industry. The firm offers its services not only in the Netherlands but also globally, and specializes in the field of population pharmacokinetics, advanced PK/PD modeling, and drug-disease modeling and simulation. In addition, Occams offers services in the area of preparation and/or review of documentation for regulatory submissions.

Seuss Consulting

Seuss Consulting provides various consulting services to companies within the Pharmaceutical, Biotech, Medical Device industries, and CRO & specialty suppliers. The firm specializes in business consulting services like Vendor Selection and Management, Outsourcing, Insourcing Strategies, and Company Analysis.

Progress-PME

Progress-PME consultancy partner for businesses in the Pharmaceutical and Biotechnology industries, as well as the Healthcare sector. The company provides knowledge and expertise in phases ranging from drug development to commercial manufacturing. Progress-PME operates primarily in The Netherlands and offers services related to Project Management, Engineering, Validation, and Quality Assurance.

PCS – Pharmaceutical Consultancy Services

PCS – Pharmaceutical Consultancy Services provides specialized services to the Pharmaceutical, Medical Devices, and related health care industries to meet current regulatory requirements. Due to its extensive network of associates, PCS can provide a specialized project team to meet all GxP/ QA/ Validation/ Training and Regulatory requirements.

Interdos

Interdos offers consultancy services for Human Pharmaceutical products, Medical Devices (CE products), and Nutraceuticals. The firm has a team of experts in a range of professional services: Regulatory Support, Clinical Studies, Pharmacovigilance Services, and Quality Assurance activities.

Regivet

Regivet is a small, independent consulting firm that specialized in the development and registration of veterinary pharmaceuticals in Europe. the company has experience in the development of different formulations like tablets, powders, injection fluids (solutions and suspensions), intramammary, and topical products. 

DGr Pharma

DGr Pharma aims to promote a fast and high-quality drug development process in close cooperation with the Pharmaceutical and Biotech companies through consultancy and contract research services. DGr Pharma provides consultancy services in early phase drug development with a focus on PK, Clinical Pharmacology, CMC, Regulatory Affairs, and IT support.

Kantisto Separation Sciences

Kantisto is an independent Chemical and Pharmaceutical analysis consultancy that offers support in practical and strategic issues through long or short-term assignments, such as Method Development, Validation, and Implementation. Furthermore, Kantisto can assist in the areas of quality by design, pragmatic quality systems, and document writing and reviewing. The firm also provides in-company training and courses.

AUTHOR! Data Analysis and Reporting

AUTHOR! provides medical writing services and data analysis support for a large number of Pharmaceutical and Biotechnical companies throughout Europe. The company works in close collaboration with international multidisciplinary clinical teams of medical professionals, advisors, regulatory affairs specialists, statisticians, data managers, SAS-programmers, and document formatting experts.

Quality RA

Quality RA is a small consultancy firm with experience in the fields of recombinant proteins, cell and gene therapy, monoclonal antibodies, and viral vaccines. The company provides advice on Regulatory Affairs (RA) and/or Chemistry Manufacturing & Controls (CMC) in the Pharmaceutical and Biotech industry.

LAP&P Consultants

LAP&P is a consulting company that provides Modelling and Simulation (M&S) services to support decision making in Drug Discovery and Drug Development for Pharmaceutical and Biotechnological companies. The firm offers consulting services in the field of Quantitative Pharmacology to answer questions that arise during the Discovery and Development phases in a quantitative way.

TOP Medical

TOP Medical has a qualified team of experts, experienced in the assessment and commercialization of Medical Devices. The consulting company addresses the growing market need for Clinical Trial Services, Logistics, Customer Service, Training, and Sales & Marketing Consultancy.

Zwiers Regulatory Consultancy

Zwiers Regulatory Consultancy provides full regulatory support for Medical Device and Pharmaceutical companies, throughout the entire product lifecycle. From initial clinical trial application to post-marketing compliance. The consulting firm’s services include Regulatory Strategic Advice, Medical Writing, Regulatory Intelligence, and Training.

Seuss Consulting

Seuss Consulting provides various consulting services to companies within the Pharmaceutical, Biotech, Medical Device industries, and CRO & specialty suppliers. The firm specializes in business consulting services like Vendor Selection and Management, Outsourcing, Insourcing Strategies, and Company Analysis.

PCS – Pharmaceutical Consultancy Services

PCS – Pharmaceutical Consultancy Services provides specialized services to the Pharmaceutical, Medical Devices, and related health care industries to meet current regulatory requirements. Due to its extensive network of associates, PCS can provide a specialized project team to meet all GxP/ QA/ Validation/ Training and Regulatory requirements.

Interdos

Interdos offers consultancy services for Human Pharmaceutical products, Medical Devices (CE products), and Nutraceuticals. The firm has a team of experts in a range of professional services: Regulatory Support, Clinical Studies, Pharmacovigilance Services, and Quality Assurance activities.

CEpartner4U

CEpartner4U serves as a consultant and Authorized Representative (AR or EC Rep) under the European Medical Device Directives. CEpartner4U services include on-site and cyber consulting for all products under the Medical Device Directive (MDD), in-vitro diagnostic Device Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD). Main areas of expertise include Regulatory Affairs, Quality Systems, Clinical Evaluation, and Training.

2BMedical

2BMedical is a small firm that develops Medical Device Concepts and provides as well consultancy as contract research to its customers. It provides consultancy services such as Business Development, Marketing, Feasibility, and Due Diligence Studies, Project and Innovation Management, Management Consultancy, Clinical Studies, Congresses, Text Writing.

Truly Translational Sweden

Truly Translational Sweden provides consultancy and experimental services within translational science in a tailored manner to support the Pharmaceutical and Life Science industry. The main areas of expertise for the firm are Strategic Project Planning, Pre-Clinical Development, Precision Medicine, and Business Development.

Phase2Phase Biopharma Consulting

Phase2Phase Biopharma Consulting provides CMC (Chemistry Manufacturing & Control) services for the Pharmaceutical and Biotech industry within the areas of Research, Development as well as Life Cycle Management of already commercialized products. 

Arex Advisor

Arex Advisor is an employee-owned company that helps Pharmaceutical companies bringing medicines to the market. Arex has a team of experts in Regulatory Affairs, Market Access, and Strategic Business Development. The firm offers strategic advice and operational expertise throughout the whole product life-cycle.

SDS Life Science

Scandinavian Development Services (SDS) Life Science are specialized in regulatory and scientific knowledge in Pharmaceutical development, Medical Device, and statistics. The company provides expert advice on formulation development, planning of both clinical and non-clinical programs, as well as medicinal product development.

Willuhn Consulting

Willuhn Consulting provides technical expertise within Pharmaceutical development and manufacturing. The consultancy firm services within areas like manufacturing and development strategies, technical investigations and problem-solving, CMO selection, contracting, and partner management, as well as CMC documentation which includes regulatory dossier writing and review.

Nordic Market Access (NMA)

Nordic Market Access (NMA) has a long and broad experience of market access in the Nordics – in therapeutic areas from highly specialized products and rare diseases to primary care products. The firm specializes in Market Access Strategy and Portfolio, Reimbursement Submissions, Health Economics, and can also provide Market Access Training.

Emmace Consulting

Emmace Consulting offers services in advising and performance testing of Pharmaceutical products on a CRO-basis. Emmace Consulting has commercial experience in developing and characterizing inhaled medicinal products. Therefore, it can help customers with planning for the development of an inhaled medication, either as a new product or a generic product.

KEY2COMPLIANCE

KEY2COMPLIANCE specializes in Regulatory Affairs, Quality Assurance, Biological Evaluations and Toxicology, and Clinical Development services specifically for Medical Device Companies for companies involved in the development, manufacturing and beyond. The firm also offers programs for Training and Education for both Pharmaceuticals and Medical device products throughout the full product life cycle.

Pharmetheus

Pharmetheus is a consulting firm that offers services focused on the application of quantitative approaches to support drug development decisions. The firm supports a wide variety of drug development decisions, including dose selection, developing pediatric development plans, investigating the potential risk for QTc prolongation, providing regulatory advice and more.

Scandinavian CRO

Scandinavian CRO is a full-service Contract Research Organisation offering both consultancy and specific, stand-alone services. The company performs complete studies or parts of projects within the field of clinical trials for both Pharmaceuticals and Medical Device. When hiring a consultant from Scandinavian CRO, you can choose between specialists, like project managers, clinical research associates, administrators, and research nurses.

Scandinavian Regulatory Services (SRS)

Scandinavian Regulatory Services AB (SRS) is a consultancy company offering regulatory expertise and services to the Medical Device, Pharmaceutical, and associated industries. SRS has a team of Regulatory Affairs and Quality Systems specialists with extensive experience from all different aspects of Regulatory Affairs and Quality covering a wide range of products.

PlantVision

PlantVision helps Life Science companies transform manufacturing, laboratory, and quality operations using a customer-centric, integrated approach. For this, the firm provides consulting and professional services together with the market’s most complete range of industry-leading solutions in this area of Life Science.

RegSmart Life Science

RegSmart Life Science is a regulatory consultancy firm that helps Medical Device and Pharmaceutical companies navigate in a complex and evolving regulatory landscape. With long regulatory and scientific experience from senior roles at the regulatory agency and from small and big Life Science companies, the firm can build your regulatory strategy in line with current thinking.

Scientific Solutions Scandinavia

Scientific Solutions Scandinavia specializes in management and specialist roles mainly within Regulatory and Medical Affairs, QA, PV, and Compliance. The firm provides clients with customized solutions of scientific professionals – temporary, permanent, or somewhere in between and is passionate about matching company needs with individual experience, personality, and commitment.

Pharm Assist

Pharm Assist is a consultant and service company offering regulatory solutions for Medical Device and Pharmaceutical companies. The company has a team with a strong scientific and regulatory background provides tailor-made services in Regulatory Affairs, Pharmacovigilance, Medical Writing, and GDP to national and international companies.

J.F.B Consulting

J.F.B Consulting has a network of consultants that brings over 40 years of experience with the goal of providing Medical Device, Pharmaceutical, and Biotechnology companies with a high level of service and dedication. The firm specializes in Strategy, Sales & Marketing, Health Economy, Market Access & Pricing, Product Planning, Supply Chain Guidance.

KEY2COMPLIANCE

KEY2COMPLIANCE specializes in Regulatory Affairs, Quality Assurance, Biological Evaluations and Toxicology, and Clinical Development services specifically for Medical Device Companies for companies involved in the development, manufacturing and beyond. The firm also offers programs for Training and Education for both Pharmaceuticals and Medical device products throughout the full product life cycle.

Clarvin

Clarvin is a consulting firm focused exclusively on Regulatory Affairs and Quality Assurance for Medical Devices. The firm has extensive experience with EU and US medical device regulations and aims to create value for its clients by providing customized strategic input to the company´s regulatory compliance scheme.

Scandinavian CRO

Scandinavian CRO is a full-service Contract Research Organisation offering both consultancy and specific, stand-alone services. The company performs complete studies or parts of projects within the field of clinical trials for both Pharmaceuticals and Medical Device. When hiring a consultant from Scandinavian CRO, you can choose between specialists, like project managers, clinical research associates, administrators, and research nurses.

Scandinavian Regulatory Services (SRS)

Scandinavian Regulatory Services (SRS) is a consultancy company offering regulatory expertise and services to the Medical Device, Pharmaceutical, and associated industries. SRS has a team of Regulatory Affairs and Quality Systems specialists with extensive experience from all different aspects of Regulatory Affairs and Quality covering a wide range of products.

SDS MedteQ

SDS MedteQ provides consultancy services within the Medical Device field. The company specializes primarily within areas like Regulatory affairs, Registration/Submission, Quality Assurance, QMS Development, Technical Documentation, Gap Analyses, Biocompatibility, Statistics, and Project Management.

PlantVision

PlantVision helps Life Science companies transform manufacturing, laboratory, and quality operations using a customer-centric, integrated approach. For this, the firm provides consulting and professional services together with the market’s most complete range of industry-leading solutions in this area of Life Science.

QARA Consulting 

QARA Consulting is a consultancy company with a team of senior, expert consultants supporting clients in the Medical Device industry. The firm offers a complete range of multidisciplinary quality and regulatory services from initial device classification, technical file writing, and clinical evaluations, to post-market surveillance.

RegSmart Life Science

RegSmart Life Science is a regulatory consultancy firm that helps Medical Device and Pharmaceutical companies navigate in a complex and evolving regulatory landscape. With long regulatory and scientific experience from senior roles at the regulatory agency and from small and big Life Science companies, the firm can build your regulatory strategy in line with current thinking.

QAdvis

QAdvis is a longstanding provider of Quality and System Management, Risk Management, Compliance, Training, Interim Management, and Regulatory Affairs. Offering a thorough knowledge and understanding of the Medical Device industry, based on 30 years of professional experience, QAdvis has the tools to help take MedTech innovations to domestic and international markets.

Scientific Solutions Scandinavia

Scientific Solutions Scandinavia specializes in management and specialist roles mainly within Regulatory and Medical Affairs, QA, PV, and Compliance. The firm provides clients with customized solutions of scientific professionals – temporary, permanent, or somewhere in between and is passionate about matching company needs with individual experience, personality, and commitment.

MedQtech

MedQtech is a consulting company with experienced professionals with high competence who support customers in the Medical Device industry within areas like Quality and Regulatory compliance. The firm can support you in writing specific processes or implementing a full Quality Management System. It also provides customized training within the regulatory and quality field in the Medical Device Industry.

Pharm Assist

Pharm Assist is a consultant and service company offering regulatory solutions for Medical Device and Pharmaceutical companies. The company has a team with a strong scientific and regulatory background provides tailor-made services in Regulatory Affairs, Pharmacovigilance, Medical Writing, and GDP to national and international companies.

J.F.B Consulting

J.F.B Consulting has a network of consultants that brings over 40 years of experience with the goal of providing Medical Device, Pharmaceutical, and Biotechnology companies with a high level of service and dedication. The firm specializes in Strategy, Sales & Marketing, Health Economy, Market Access & Pricing, Product Planning, Supply Chain Guidance.

Fjord Consulting

Fjord Consulting performs consulting services in the areas of Quality Management, Product Development, Project Management, Training, and Product Registrations. The main branch is within the Medical Device and the Life Science industry. The firm has consultants with more than 12 years of experience in leading positions within this area.

Devicia

Devicia provides full-service solutions and consultancy services within the Medical Device industry. The firm specializes in Quality, Regulatory, and Clinical Affairs. Therefore, it offers full-service solutions within Medical Writing, Clinical Investigation consultancy services, Regulatory Affairs, and Training modules within regulatory and clinical processes.

THAY Medical

THAY Medical is a new innovative Human Factors Engineering consultancy based in the UK. They are an organization focused on providing expertise on human factors for medical products. This includes medical devices, healthcare systems, and pharmaceutical (Drug delivery) devices.

ECT Healthcare Consultancy

ECT Healthcare Consultancy provides Regulatory, New Product Development, and Commerical consultancy services to the Medical Device and Healthcare Technology Industries. Collaborating with cutting-edge healthcare SMEs and larger OEMs. 

Sensus Group

Sensus offers specialist consultancy, training and resource in delivering and implementing compliance of the new EU medical device (EUMDR 2017/745) and in-vitro (IVDR 2017/746) regulations.  

Haughton Design

Haughton Design’s product design & medical device development services were created to deliver a first-class solutions to their clients. They provide a complete package, from concept design to industrialization, rather than just producing ‘aesthetic, blue sky’ design work.

Psephos Biomedica

Psephos Biomedica was founded in 2001 and works with clients from around the world to help them bring medical technologies to market. They pride themselves on high focus and experienced team.

Advena Medical

Advena Ltd. was founded in 1996 and provides cost-effective regulatory affairs consulting services to small and medium-sized medical device manufacturers and distributors seeking to import their medical devices into the European Union.

Meddev Solutions

Team of experienced UK based medical device consultants, working in the medical device industry for both manufacturers and notified bodies. Meddev was voted the ‘Best-In-Class’ Medical Device Regulatory Consultancy company of 2020 by MedTech Outlook magazine.

Flintloque Management Systems

Flintloque implements an International Management System Standard to help their customers access restricted markets and get a step ahead of their competition. Flintloque is a leading consultancy with rich experience.

Confinis

Regulatory consultancy specializing in providing advice and services to the medical device, combination product, and IVDD manufacturers.Particular expertise in new product development from idea through registration to commercialization and post-market activities.

Triune Technologies

Medical Device Consultancy that offers hands-on support for quality systems, including ISO 13485, 21 CFR 820, CMDCAS, auditing, gap analysis, mock regulatory inspections, process validation, regulatory submissions on 510k, CE Mark.

Sterile Management Systems

Auditing, training and consultancy services for medical device industry with a focus on design, quality management and regulatory compliance and special expertise in decontamination and sterilisation.

Arevna Consulting

Arevna Consulting is a global solutions provider with over 20 years’ industry experience specializing in Quality and Regulatory compliance for Small, Medium, and Large scale Medical device manufacturers.

Springboard Pro

Springboard specializes in the development of medical devices from concept to manufacture for regulated markets.

Prosum Medical

Prosum specializes in the design, development, manufacture, commercialization, and distribution of medical devices for the global healthcare market. ​

Lorit Consultancy

Lorit Consultancy offers consultancy, support, training and online-courses in functional safety related projects in the medical, automotive and reliability sectors. Medical: IEC 60601-1, IEC 62304, ISO 14971, IEC 62366-1, AAMI TIR57 Automotive: ISO 26262, Automotive SPICE®, SAE J3061, IEC 61508 Reliability: IEC 61709, SN 29500, FIDES and DO-178C and DO-254 Quality Management: IATF 16949, ISO 13485 and ISO 9001

AlacraMed

Alacramed was formed as a spin-out from leading biopharma life science consultancy Alacrita. This allowed Alacramed to enhance its focus on a growing number of medical device clients.

GMP Healthcare

A team of more than 30 permanent professionals that includes experienced pharmaceutical consultants to provide support and advice across the product life-cycle. 

International Device Solutions

Independent and nonexclusive consultant and subject matter expert for global pharmaceutical, medical device, financial and legal companies. From unmet needs to manufacturing control and scale-up.

Clarity Compliance Solutions

Clarity Compliance Solutions is a leading international consultancy providing a wide range of compliance services for the regulated industries including Pharmaceutical, Biotech, Research & Development, Blood, Medical Device, and associated equipment and system suppliers.

Datod Consulting

Datod provides process improvement and change management consultancy to small to medium-sized organizations helping them unravel complexity from their organizations. Particular focus on improving Quality Management Systems to improve efficiency, effectiveness, and compliance.

Guide Consulting

Established to support small to medium-sized businesses with developing and maintaining their management system. Services include ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 22301, and ISO 13485.

Commala

Commala specializes in the development of medical devices and combination products, including planning, project managing, design history file compilation, and safety risk management. More than 13 years of experience in Pharmaceutical Medical Device and Combination Product development.

The Electrospinning Company

Electrospinning supports the development of electrospun medical devices from concept or prototype to the market with over 30 years of combined experience in biomedical electrospinning.

Clarity Compliance Solutions

Clarity Compliance Solutions is a leading international consultancy providing a wide range of compliance services for the regulated industries including Pharmaceutical, Biotech, Research & Development, Blood, Medical Device, and associated equipment and system suppliers.

International Device Solutions

Independent and nonexclusive consultant and subject matter expert for global pharmaceutical, medical device, financial and legal companies. From unmet needs to manufacturing control and scale-up.

Repower Quality

Owned by Rebecca Power, Repower Quality provides Quality Assurance consultancy and Electronic Quality Management System (EQMS) implementation support, primarily to the cGMP-regulated Pharmaceutical and Biopharmaceutical industry in Ireland.

GMP Healthcare

A team of more than 30 permanent professionals that includes experienced pharmaceutical consultants to provide support and advice across the product life-cycle. 

H2 Pharma Consulting

H2 Pharma Consulting is a specialist Consultancy Group providing comprehensive product development services to the Biotech and Pharmaceutical Industry, Research Institutions, and Academia. The scope of their services spans the spectrum of drug product development activities from early pre-clinical evaluation through to full development and product registration.

Pharma Quality Partners

Pharma Quality Partners Ltd was established in 2013 with the vision of achieving “Quality Excellence Through Partnership”.  Their Consultancy includes GMP, Pharmaceutical Quality Assurance, and Qualified Person related services.

QVigilance

QVigilance is committed to delivering quality-driven pharmacovigilance services with a focus on clinical trial and post-authorization needs.

The GMP Group

The GMP Group is an international consulting company with over 40 years’ experience in Pharmaceutical Validation and Compliance Validation of Processes in line with Regulatory Requirements.

Compliance Angels

Compliance Angels, a consultancy company, which provides comprehensive, expert, and quality compliance advice and services to the pharmaceutical industry.

Drive Phase PV

Drive Phase PV provides pharmacovigilance and device-vigilance support and auditing in both clinical and post-marketing settings, with particular expertise in oncology and biologics.

bioSynergy Consulting

bioSynergy Consulting is well connected within the industry and works closely with a wide range of experts in manufacturing, testing, quality, and regulatory affairs.

Alacrita Consulting

Alacrita is ready to support you through every step of the pharmaceutical product development process, leveraging their scientific, clinical, and commercial expertise to help you maximize value at each stage.

Strickland Quality Assurance

Strickland Quality Assurance is an independent QA consultancy providing bespoke GCP services for the healthcare industry. All types of clinical audit and regulatory inspection support are available.

ZigZag

Zigzag has offices located in the UK, USA, and Singapore as well as a consultant network that extends our team to more than 70 experienced QA professionals based around the world.

CommQP

Mukesh Patel established CommQP with the purpose of providing a combination of technical and commercial consultancy services with a main focus on the Pharmaceutical sector.

Purple Vigilance

The aim of Purple Vigilance is to ensure patient safety, whilst maintaining compliance with legislative requirements. They aim to provide high quality and cost-effective solutions, to support the requirements of companies of all sizes.

Iolite Pharma Consulting

Iolite Pharma Consulting offers a combination of Quality Assurance and Regulatory Affairs expertise, supported by a considerable senior management experience.

Semper Vigilance

Semper Vigilance is an innovative company based in London that currently works with a number of pharmaceutical companies to help meet their pharmacovigilance requirements.

Nordic Pharma Consulting 

Nordic Pharma Consulting has solid know-how in various Pharmaceutical areas. It offers services within Project Management, Consulting, Personal Management, Business Strategy, Implementation of Business Opportunities, Industry Assessment, Business Process Optimization, Strategic Performance Measurement & Reporting, Innovation & Patents, as well as People Management.

NORD Pharma Partners

NORD Pharma Partners offer a variety of consulting services for the Pharmaceutical industry in the EU. The company can assist with a specific task, as well as provide a permanent or long-term solution in core areas of expertise: Regulatory Affairs, Pharmacovigilance, Contract Manufacturing, Clinical Trial Supply, and QA/QP Services, GMP.

Billev Pharma

Billev Pharma specializes in Regulatory Affairs and Pharmacovigilance for the Pharmaceutical industry and helps in situations where the companies in question either have no specialized staff or have too little capacity. Over the years the consultancy assisted companies with assignments ranging from national registrations over the Mutual Recognition to Decentralised and Centralised procedures.

Zealth

Zealth helps healthcare companies, including Pharmaceutical firms bring their products to patients. The consulting firm aims to break down the silo mentality when it comes to sales, marketing, medical and corporate affairs. Thus, its area of expertise is Marketing, Pricing, Reimbursement & Access, Medical Affairs, and Health Economics.

TriTiCon

TriTiCon is an eClinical consulting company with expertise in Clinical Data Processes and Systems. From strategy to end-user training, the TriTiCon can help Pharmaceutical companies all the way in establishing their end-to-end solution for handling clinical data. The firm focuses on areas like Subject Matter Expertise, Strategic Understanding, and Project Management.

Sply

SPLY is a clinical trial supply consultancy and technology company working closely with innovative Pharmaceutical and Biotech organizations. The company provides consulting services wihtin clinical trial supply management and project management based on technical expertise combined with a broad understanding of the business processes within the clinical area.

Solural Pharma

Solural Pharma has strong expertise in all aspects of Pharmaceutical development and uses this to offer consultancy support to solve CMC development, and project management needs as well as CRO/CMO expertise providing solutions for low soluble oral drugs.

Genau & More

Genau & More provides a wide range of compliance services to Life Science companies to ensure that patient safety is never compromised and that the organization is always inspection-ready. Some of the onsite and offsite services that Genau & More offers are project management, validation, training, quality & compliance.

SAXOCON

SAXOCON helps Pharmaceutical, Medical Device, and other product manufacturers test, document, and certify that their products are in compliance with regulations and guidelines. For Pharmaceutical companies firm offers services within areas like Drug Substances & Products Manufacturing, and Pharmaceutical Development stages.

IWA Consulting

IWA Consulting is a group of regulatory affairs specialists providing expert services to a range of international private and public clients within industries like Medical Device, Biotech, and Pharma. The consulting firm has long-term experience within regulatory affairs, in-depth knowledge, and an understanding of the sense of urgency that applies to this business area.

Pharmaceutical Engineering Consultants (PEC)

Pharmaceutical Engineering Consultants (PEC) is an innovative engineering consultancy that assists and manages projects within the Life Science industry. The firm has grown into one of the leading consultancy companies in Denmark within the field of production of Pharmaceuticals, Medical Devices and can contribute to most phases of a device project.

SPT VILECON

SPT VILECON is offering customer-oriented consultancy, design, development, and construction services to the Medical Device and Pharmaceutical industries. The firm specializes in between design, development, and construction of Medical Devices on one hand, and injection molding on the other.

Emendo Consulting Group

Emendo Consulting Group’s background-origin is within the Pharmaceutical and Food industry, but nowadays the company works across all industries, including Medical Device and Pharmaceutical. The firm provides unique process expertise to all phases of a product lifecycle, from early development, the establishment of new equipment/production facilities to process optimization.

AlfaNordic

AlfaNordic is a consulting company with more than 90 employees working in the Life Science industry. The firm specializes in Pharmaceutical production, Project management, Management consulting, Validation, Production support, IT/AUT, QA/QC, Medical device, Regulatory Affairs (RA), and Pharmacovigilance (PV).

Sigma Quality & Compliance

Sigma Quality & Compliance offers consultancy services within various processes such as production, product development, research, testing, and purchasing. The company has a long and solid experience in Life Science, including Medical Device and Pharmaceutical and other quality-controlled businesses. 

Borgensgaard Consulting

Borgensgaard Consulting provides a variety of consulting services to companies in the Life Science industry like Medical Device, Pharmaceutical, and Biotech but is also very relevant for other industries. The firm specializes primarily in Quality Leadership, Quality Management, Regulatory Compliance, and Human Behavior.

Aquilo Consulting

Aquilo Consulting is an international management consulting firm specialized in developing and implementing growth strategies for private healthcare companies and public healthcare organizations. The company helps Medical Device, Pharmaceutical companies, and other healthcare providers grow the quality, efficiency, and profitability of their businesses.

PHARMAKIA

Pharmakia is a Private Limited Company managed by an owner who is also a consultant. The owner of the consulting firm, Stephane Labrosse, can help you in the areas of Project Management, Quality Assurance, Regulatory Affairs, Validation, and Technical Expertise in Medical Device and Pharmaceutical development.