The overall activities are of regulatory affairs are to obtain Marketing Authorization’s for generic products. We support the entire drug approval process which involves;
- Preparation of Drug Master Files in CTD format and Technical Dossiers including finished product dossiers in e-ctd format.
- Support for marketing authorisation applications.
- Answering of deficiency letters
- Maintenance, support and optimisation of your marketing authorisations.
- National variations and EU variation procedures.