Regulatory Affairs
Dossier Preparation & NDA Submission
Assisting with comprehensive dossier preparation and streamlining New Drug Application (NDA) submissions.
Compilation and Review of CMC
Coordinating Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory excellence.
Preparation of Common Technical Documents (CTD)
Managing modules 1 to 5 to ensure regulatory submissions are complete and compliant.
Regulatory Strategy and Clinical Development Planning
Offering strategic planning to navigate the clinical development and regulatory landscape.