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)
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.