• Gap analysis
  • Due diligence
affairesreglemantaires- activite_enregistrement

Registration activities

  • Definition of status of the product (drug, medical device, cosmetics,…)
  • Definition 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
  • Environmental Risk Assessment (ERA) writing
  • Risk Management Plan (RMP) writing
  • Risk Analysis for Elemental Impurities (ICH Q3D) writing
  • Risk Analysis for Nitrosamines writing
  • CEP file and Active Substance Master File (ASMF) writing
  • 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

  • Management of administrative, Quality, Non Clinical and Clinical Variations
  • 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 exemption from list of poisonous substances
  • Handling and transfer of MA, change of marketing company (“Exploitant”)
  • Regulation related to pharmaceutical and medical devices promotional materials

Experience special drugs

  • Drug-Device combination products
  • Herbal products
  • Medical gases

We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.

Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.

53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00

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