Registration: Drafting & Submitting MA files

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

Analyzing regulatory prerequisites according to the registration procedure (CP, DCP, MRP, national)

  • 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
  • Direct contact with the 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, 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.