Case Study 117: Local Testing of Drugs During ANDA Registration China
The client is a multinational company has filed ANDA in China for 2 generic drugs. As part of the registration process of the generics in China, NMPA requested them to conduct the local testing
Case Study 112: Local testing for DMF API Registration in China
The client is an American manufacturer of APIs needed support with local testing in China to complete the registration of the DMF in China.
Case Study 61: Pharmacovigilance Outsourcing: Literature Screening in China and Macao
The Client is a multinational pharmaceutical company with affiliate in China, that was looking for a qualified PV service provided in China
Case Study 118: Registration of API DMF in China
Client is a multinational company, leader in the production and supply of APIs for radiopharmaceuticals and radioisotopes looking for local partner who can guide them through the process and help them register their DMF with Chinese health authority NMPA.
Case Study 8: Registration of DMF for Packaging Materials in China
Client was looking for a partner in china that can register a DMF of their packaging material, the transdermal delivery system used for drugs presented in dermal patches. in China for them.
Case Study 31 : China Regulatory Intelligence for US Based Pharmaceutical Company
Client was exploring possibilities to register new drugs in China and wanted to understand comprehensive landscape for new drug registration,