Investigational Device Exemption (IDE) Preparation and Submission to FDA
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.
DMF Registration in China for a Leading US Based API Manufacturer
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.
Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia
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
Generic Drug Registration with NMPA in China
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
Registration of Vaccines with Anvisa in Brazil
. A global vaccine manufacturer wants to expand its presence in Latin American countries. Client needed a partner with regional presence in Brazil and experience in vaccines or biologics products registration in Brazil.
Transfer of Marketing Authorization in Argentina for a Biologic
The Client is a UK based specialty pharmaceutical company that did not have a local presence in Argentina and was seeking a trusted partner to initiate license transfer in Argentina and act as its legal representative in Argentina.
