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:
- Current regulatory status of drugs in EU and US markets
- Current GMP status and availability of reports from clinical studies conducted in country of origin
- Teams available to support with registration of drugs in China
