Qualified experts in Chemistry, Manufacturing & Controls (CMC) comprises scientists with the in-depth experience to ensure the robustness of their CMC capabilities. They are with the following scopes: (1) Communication with the API and finished product manufacturer (2) Compilation of modules 2-5 in eCTD format (3) Assessment on Authorities’ commentaries for Modules 2-5 and design of response approaches (4) Raw data evaluation for compliance as per ICH guidelines (5) Coordination with experts for the non-clinical and clinical overviews’ preparation (6) Compilation of response documents for Modules 2-5 within a set timeframe (7) Gap analysis maintenance (8) Handling of variation filings.