From Concept to Proof of Concept info@advinus.com   

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