Case Study 62: DMF Registration in China for a Leading US Based API Manufacturer

Company Situation

Client is a US based, global Contract Manufacturer of Active Pharmaceutical Ingredients (APIs) and specialty chemicals. The Client’s customer, a finished drug manufacturer, planned to launch its pharmaceutical product in China. Therefore, the Client required to file a DMF in China in order to maintain the confidentiality of their manufacturing process and other API related information using a Drug Master File (DMF) strategy. Considering Client had no experience with DMF registration in China, it reached out to Global Regulatory Partners (GRP) as a Strategic Partner that could manage end to end regulatory responsibilities for it in China right from Drug Master File registration, Legal Representation and Lifecycle Maintenance.

GRP Solution

GRP stepped up as a Strategic Regulatory Partner for the client for its business expansion in China. GRP has built efficient templates and checklists, based on its decades of experience with NMPA, that was provided to client to be prepared with set of documents required for DMF preparation. Using agile project excellence methods for regulatory submissions, GRP enabled gap analysis, compilation and translation of submission package in Chinese language in timely manner. Further, GRP utilized its network with the NMPA to proactively address queries during the preparation of DMF to avoid delay in approvals post submission.

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