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)
Writing, reviewing and compiling MA files for France, Europe and export
- 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
Managing the registration procedure until obtaining the MA
- Direct contact with the health authorities,
- Answering questions
- Managing the national phase of European procedures (product information, labelling, packaging items)
Publishing your files in eCTD format
- Use of recognized folder publishing software
- Access to our secure file exchange platform
Submitting your files to the authorities
- Use of European platforms (CESP, eSubmission, PSUR Repository)
Further information
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.