Achievements

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.

Provision of EU QPPV for 35 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.
More than 10 years of experience.
Over 50 active clients.

Established collaborations with multinational pharma companies.
Hundreds 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.
Hundreds 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.

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.

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).