Affaires réglementaires
PHARMACEUTICAL

Audits

  • Gap analysis
  • Due diligence

Registration activities

  • Définition of status of the product (drug, Medical Device, cosmetics,...)
  • Définition of the registration strategy
  • Writing of MA applications (Modules 1 to 5) in European (DCP, MRP, CP) or national procedures
  • Application files outside UE
  • SmPC preparation, patient information leaflet, labeling
  • Realization of readability tests
  • Writing the Environmental Risk Assessment (ERA)
  • Drafting of the Risk Management Plan (RMP)
  • Risk Analysis Writing for Elemental Impurities (ICH Q3D)
  • Risk Analysis for Nitrosamines writing
  • CEP file writing and Active Substance Master File (ASMF)
  • eCTD formatting (baseline) and publishing
  • Electronic submission on behalf of clients (CESP portals, Web Client)
  • Follow-up of procedures and exchanges with the health authorities
    • on behalf of our customers (handling of MA)
    • as a contact person authorized by our clients

Regulatory maintenance activities

  • Administrative Variations, Quality, Non Clinical and Clinical
  • Requests for changes to information (DMI)
  • Extension of therapeutic indications
  • MA renewal
  • Determination of the positioning of variations
  • Submission strategy (grouping, worksharing)
  • Request for exemption (sunset clause waiver)
  • File application for non-prescription OTC medicines or free access products
  • File application for exemption from list of poisonous substances
  • Handling and transfer of MA, change of marketing company (“Exploitant”)

Experience special drugs

  • Herbal products
  • Medical gases