Regulatory Affairs

     Presentation

• Experience
  • Submissions to the French Medicines Agency (Afssaps) and other Regulatory Agencies in Europe
  • Participation in Afssaps working groups and knowledge of Afssaps procedures
  • In-depth expertise with the European Clinical Trial Directive
     
• Services
  
  • Advice in Submission strategy
  • Certified translations of regulatory and clinical documents
  • Preparation of  IMP dossier
  • Preparation and submission of CTA documents
  • Management of potential questions raised by Afssaps or other European Authorities
  • Management of  substantial amendments
     
• Staff
  
  • Highly experienced team in Regulatory Procedures and file submission

  Expertise

  • Regulatory submission
    Preparation and submission of a CTA in one week. Submission to Afssaps may be done each Monday and Friday with acceptability (recevabilité) of the application within five days.
     
  • 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 : 

             Afssaps (French Medicine Agency): http://afssaps.sante.fr/htm/5/essclin/indesscl.htm

             Phase I clinical trials: http://eudract.emea.europa.eu/ 

  For more information on our Regulatory Affairs Department, please contact us:
  contact@biotrial.com