Review, compile and Preparation of original drug master file (DMF)/ ASMF as per GUDFA guidance/EMA guidance in eCTD format for various agencies. Review, compile and Preparation of Response to Deficiency as received from Agency. Working on Life Cycle management of DMF including amendment, biannual update, Annual Reports etc. for various markets. Preparation of Applicants Part and sharing with Customers and resolving customers query. Sound knowledge about ICH guidelines GDUFA and EMA guidelines
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