Clinical Trials

  • Extensive experience including all therapeutic areas with the majority of clinical trials being in Oncology, CNS, Respiratory, Cardiology, Diabetes and Hepatology.
  • More than 83 trials of several designs/phases (Interventional/Observational, PhII-PhIV, multi-center, national/multinational) with more than 16.000 Patients and more than 1180 Study Centers.
  • Certified by the French Ministry of Higher Education and Research as an approved organisation for carrying out R&D activities for the account of private companies.
  • Active participation in R&D projects of basic research with the aim to develop and invest in innovative new health technology.
  • Continuous collaboration with over 160 Key Opinion Leaders.
  • Management of thousands of study centers.
  • Team of 14 experienced professionals.


  • Provision of EU QPPV for 20 pharma companies.
  • Provision of Local QPPV/Deputy for 15 multinational pharma companies.
  • Assessment of PV Quality System via 30 external Audits by international pharma companies/Contract Safety Surveillance Organisations (CSO) with successful outcomes (no critical findings).
  • Own validated safety database (Empirica Trace® ORACLE).
  • More than 10 years of experience.
  • Team of 15 experienced professionals.
  • Over 50 active clients.

Regulatory Affairs

  • Established collaborations with over 100 clients more than 40 of whom are foreign or multinational pharma companies.
  • More than 100 due diligence dossier reviews, including gap analyses of Quality and CMC documentation.
  • For more than 10 multinational pharma companies, Pharmassist functions as their sole RA representative, providing full regulatory support.
  • Hundreds of due diligence dossier reviews, including gap analyses of Quality and CMC documentation.
  • Hundrends of MRPs/DCPs/NPs.
  • Thousands of CMC variations.
  • Trusted partner during several major multinational pharma mergers and acquisitions for Marketing Authorisation transfers and other regulatory activities.
  • Established network of experts in 33 EU Countries.
  • More than 18 years of experience.
  • Team of 20 experienced professionals.

Medical Affairs

  • Preparation of Briefing Documents in the context of seeking Scientific Advice from EMA and other EU Regulatory Authorities.
  • Successful preparation of CTD Module 2, 4 and 5 documents.
  • Organization and conduct of Scientific Advisory Boards.
  • Preparation and publication of scientific articles.
  • Extensive experience in medical evaluation of PV data.
  • Preparation of study documents for several clinical studies.

Quality Management

  • Certified since 2011, according to ISO 9001 standards.
  • Frequently audited by major Multinational Pharmaceutical Companies for quality of services.
  • Successfully assessed through 2 Ethical Assessment/Workplace Conditions Assessment (WCA).