Eurofins Advinus is offering the regulatory services on the following apart from entire gamut of regulatory studies and are;
- Development of project plan for the NCE for IND
- Dossier preparation/IMPD document for regulatory submission
- Preparation of CTD modules with summary tables as required for submission to FDA
- SEND capability for the studies to submit the data in SEND form to FDA
- Investigative Brochure (IB) preparation