A major Pharmaceutical company, based in India, faced a challenge in review and update of a Module 3 and Quality Overall Summary for a Biosimilar product (mAb) in preparation for a European submission. The product was going to be manufactured in China, thus GMP compliance was another issue to be looked into. The product was planned to be submitted via the Centralised procedure according to stringent Company deadlines, prior to which a pre-submission meeting was planned with the EMA. RegPak consultant reviewed and updated the submission documents and provided a corrective action list for the manufacturing site. The client reviewed the Site Master File and suggested the pre-submission activities to be performed