➢ Preparation and compilation of ACTD dossiers for Vietnam, Myanmar, Cambodia, Philippines and
ROW market
➢ Dossier preparation as per the ACTD (Part I, II, III and IV) guidelines.
➢ Review of documents for its correctness and compliance with respective regulatory guidelines (as per
country requirement).
➢ Preparation & Review of Process Validation, Analytical Method Validation, Product Development
Records.
➢ Preparation & Review of Specification, Method of analysis of Excipients, Drug substance, Finish
product, Stability data, COA of raw material, finished product and Packing materials etc.
➢ Review of DMF.
➢ Knowledge of COPP, Product permission, GMP certificate, Mfg. License, Site master file, Letter of
Authorization, Summary of product characteristics and Patient Information Leaflet (PIL).
➢ To Prepare check & review Artworks, Labels, and Package inserts.
➢ Co-ordinate with departments such as Manufacturing, Product Development, QA/QC, R&D, Legal,
purchase etc. to ensure availability of documents and samples for submission.
