Regulatory Consultant

Innoten Co.Ltd  is  Leading Regulatory and Registration Service provider in writing Dossier,DMF,CTD,ACTD,eCTD and compilation of all kind of registration files and submission.
We provide regulatory consulting and dossier solution for export registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).

Administrative Documentation (writing and review):
  • Registration Application & Covering Letter
  • Letter of Authorisation
  • Legal & Administrative (GMP,CoPP, FSC etc) Documents
  • Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
  • Label and carton contents
  • Global Patent Information and Literature for patented product
  • PSUR (Periodic Safety Update Reports)
Technical Documentation (writing and review):
  • Summaries – Quality, Clinical & Non-clinical
  • Drug master file (S Part of Dossier)
  • Clinical & Non-clinical Overview (Module 2)
  • PDR, Process validation, AMV & Stability Studies
  • Specification, Method of analysis & Certificate of Analysis of Raw materials & Packing Materials
  • Specification, Method of analysis & Certificate of Analysis of Formulation product
  • Module 4 (Non-clinical)
  • Module 5 (Non-clinical)