Client is a USA based, global Contract Manufacturer of Active Pharmaceutical Ingredients including specialty chemicals. The Client’s business partner planned to market generic drugs in China using APIs from the Client.
The Client is a South Korea based medical devices manufacturer who has developed a glucometer that it wanted to launch in Japanese market.
The Client is a China based invitro diagnostic kits manufacturer planning to launch its IVD kits for Human Papilomavirus (HPV) detection kits in USA and was seeking a partner to provide a clinical investigation strategy for the kit and support with preparation and submission of investigational device exemption (IDE) application to FDA.
US based, global Contract Manufacturer of Active Pharmaceutical Ingredients (APIs) and specialty chemicals. The Client’s customer, a finished drug manufacturer, planned to launch its pharmaceutical product in China. Therefore, the Client required to file a DMF in China in order to maintain the confidentiality of their manufacturing process and other API related information using a Drug Master File (DMF) strategy.
US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets
European based generic drug manufacturer who wants to expand to China seeks GRP as a partner to 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