Case Study: Generic Drug Registration with NMPA in China

Company Situation

Client is a Europe based generic drug manufacturer who was seeking to expand its presence in China. Client did not have presence in China and had no prior experience with NMPA regulatory process. Client was seeking a partner that can develop the appropriate regulatory strategy of the generic products in china, conduct the bioequivalence in china and register the products in china on its behalf and assist with planning its commercialization and regulatory strategy for China.

GRP Solution

GRP was retained by Client as a preferred partner in China for commercializing the entire portfolio (about 15) of generic drugs over a period of 3 years. GRP assessed Client’s portfolio and developed the appropriate regulatory strategy for the registration of each generic product in china   based on Chinese regulatory requirements, available technical data and available local resources.

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