Clinical & Regulatory Documentations

MEDICEPTION provides high-standard and cost-effective regulatory documents to our sponsors and clients. Our expertise is to prepare error free documents in minimum turn around time. We provide full registration, dossier services, responses to queries, regulatory support to sales and product globalization.

Some of our capabilities are listed as:

  • Regulatory Documents CTD, Dossiers

    • eCTD (sections II-V)

  • Information Consent Form (ICF), Investigator's Brochure (IB)

  • IND / ANDA applications 

  • Regulatory CMC

  • Product monographs 

  • Leave Behind Literature (LBL)

  • Safety Narratives, SAEs, PSURs

  • Toxicology Reports

  • Patent searches, Drafting & Indexing