· Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market · Preparation of query response of drug substance for various and less regulated markets and customers. · Preparation of applicant part and closed part for various authorities for different customers. · Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, · Preparation and submission of CEP applications and responses to EDQM via CESP. · Preparation of CEP LOA’s & LOA’s and declarations of various customers and authority. · To collect and evaluate scientific data for assessment and prepare regulatory submission for authorities and customers
