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GRP is licensed by the local health authority (NPMA) to act as your Local Representative (RP) in China.

GRP-China services the Representation, Regulatory, product registration, compliance, safety and life cycle Maintenace of our clients’ products in China. 

GRP China Team is bilingual in Chinese and English. 

Please note: National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.

GRP specializes in the Health Regulated Products certainly for the BioPharma and BioTech field. 

• GRP supports Pharma sponsors in registration of Biologics, Biosimilars, Radio-pharma, Chemical New Drugs, Generics and various DMF Categories (API, packaging, and excipient). 
• GRP Support Biotech Manufacturers in their registration of Medical Device and IVDs. 
• GRP supports the regulated consumer health products such as Food Supplements, Cosmetics and OTC. 

Yes, there are some available programs developed by the government for expediated market access into China. For clients to know if they qualify, GRP must do a feasibility assessment. GRP China is a qualified partner with these governmental program offices. 

Yes, as your local representative GRP China supports the Sponsor in local protocol development and CDE consultation meetings and negotiations. Once CDE consultation meetings are complete, GRP prepares and submit the Clinical trial application.  GRP China has qualified CRO Partners in China that support our clients for local studies. GRP China Quality Auditors – audit local sites to ensure they comply with GCP standards. 

Yes, we have experience in preparing and submitting the DMF for API, Excipient and Packaging.  As Local Testing is also required in China, GRP China project manages the local labs and importation of samples.

Yes, GRP-China PV team supports clients with Pharmacovigilance monitoring activities in Mainland China and Macao.