Our experts in regulatory affairs...

Our offerings

stage1 :BRINGING DRUGS TO MARKET

  • Strategy for registering/submitting marketing authorisations, simplified marketing authorisations, etc.
  • Drafting of the CTD:
    • Administrative data & data relating to the correct use of the drug (Module 1): SPC, Labelling, Package leaflet, etc.
    • Scientific data relating to the drug (Modules 2 to 5): quality summary, non-clinical, clinical, chemical, pharmaceutical, clinical studies, etc.
  • Support operations in the fields of pharmacovigilance & risk management (Dir. 2010/84/EU)

stage2 :KEEPING DRUGS ON THE MARKET

  • Updating of drug files as and when updated drug manufacturing and monitoring methods emerge
  • Communication of any new information relating to the drug (off-label use, pharmacovigilance, etc.)
  • Updating of the Marketing Authorisation (extension, modification of type - IA, IB or II, etc.) / Reformatting
Contact one of our specialists
news PHARMACEUTICAL