Regulatory Services

Apart from the whole range of regulatory research, Mavens provides regulatory services for the following:

• 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.