Core Regulatory Services -

We can help you prepare entire registration file for Drug/Food/Nutraceutical product registration in various countries all over the world.

  • eCTD / CTD / ACTD / Country specific dossier registration of all type of products (Global Regulatory Affairs) 
  • Dossier Compilation and writing as per CTD Format – Common technical Document
  • Module 1 – Administrative Information
    Module 2 - CT Overview
    Module 3 – Drug & Product Part /CMC
    Module 4 – Non Clinical
    Module 5 – Clinical

  • Dossier writing and compilation as per ACTD Format – Asian Common Technical Documents
    Part I – Administrative Documents
    Part II – Quality Documents
    Part III – Non Clinical Documents
    Part IV – Clinical Documents.

  • Analytical Method Validation (AMV) and Process Validation (PV)
  • BE Studies
  • Clinical and Non Clinical Studies
  • Expert Reports​
  • Periodic Safety Update Reports (PSUR) and Risk Management Plans
  • Summary of Product Characteristics (SmPC) and Pack Insert

Our Services