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
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.
US based dietary supplement company seeks GRP as a partner to help them comply with local regulations and enable them to sell their products in Mexico through Amazon.