• Pharmacovigilance and regulatory affairs specialists - Biotrial

Regulatory Affairs & Pharmacovigilance

Experience

  • Submissions to the French Medicines Agency (ANSM) and other Regulatory Agencies in Europe
  • Participation in ANSM working groups and knowledge of ANSM procedures
  • In-depth expertise with the European Clinical Trial Directive
     

Regulatory Affairs Services

  • Advice in Submission strategy
  • Certified translations of regulatory and clinical documents
  • Preparation and submission of Clinical Trial Application (CTA) documents
  • Preparation of  Investigational Medicinal Product Dossier (IMPD)
  • Preparation of Investigator Brochure (IB)
  • Management of potential questions raised by ANSM or other European Authorities
  • Management of  substantial amendments

 

Pharmacovigilance services

  • Eudravigilance management (initial registrations, IMP declaration, SUSAR declarations)
  • Serious Adverse Event (SAE) collection and processing
  • Suspected Unexpected Serious Adverse Reactions (SUSARs) submission to competent authorities and ethics committees
  • Development Safety Update Report (DSUR) or Periodic Safety Update Report (PSUR) writing and submission

Expertise

  • Regulatory submission
    Preparation and submission of a CTA in one week
  • Regulatory monitoring
    Constant monitoring of new regulatory evolutions through key contacts, internet watch and scientific review
  • Regulatory Consultancy
    Our team offers Regulatory Consulting services concerning specific processes and regulations in France before and during the clinical conduct of the study.

 

Useful links:

ANSM (French Medicine Agency): http://ansm.sante.fr/

Phase I clinical trials: http://www.ema.europa.eu/ema/