Case Study 64: 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 for commercialization of its portfolio of generic drugs. Client did not have presence in China and had no prior experience with NMPA regulatory process. It was seeking a partner to assist it with planning its commercialization and regulatory strategy for China and support through the process of registration of generic drugs by being a local partner.

GRP Solution

GRP was retained by Client as a preferred partner in China for commercializing its entire portfolio (about 15) of generic drugs over a period. GRP assessed Client’s portfolio and engaged in a strategic workshop to assess:

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