Registration: Drafting & Submitting MA files

Atessia accompanies you throughout the entire registration process: from drafting to submitting your MA files.

  • Scientific advice and protocol assistance with authorities
  • Pre-submission meetings with authorities
  • Assistance with our network of recognized pharmaceutical, non-clinical and clinical experts
  • Analyzing regulatory prerequisites according to the legal basis and registration procedure (CP, DCP, MRP, national)
  • Management of readability testing of PIL
  • Modules 1 to 5 of the MA dossier
  • For all types of drugs: chemical, biological and biotechnological (advanced therapy drugs) or plant-based
  • Reformatting National or European files for export files
  • Exchanges and coordination with national and European health authorities
  • Answering questions
  • Managing the national phase of European procedures (product information, labelling, packaging items)
  • Use of recognized folder publishing software
  • Access to our secure file exchange platform
  • Use of European platforms (CESP, eSubmission Gateway, PSUR Repository)

Further information

Download the document "Chemistry, Manufacturing, and Controls (CMC)"
Download the document "L'enregistrement des médicaments humains et vétérinaires"

Thanks to its team of consultants specialized in publishing, Atessia can take charge of your project from A to Z: from writing to submitting your MA files.