Registration of DMF Type II with FDA
Client was looking for a local agent to support the registration of a type II DMF with the FDA for the serum CellCor.
DMF Registration in China for a Leading USA Based Contract Manufacturing Company
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.
Registration of Glucometer (Class III In-Vitro Diagnostic) in Japan
The Client is a South Korea based medical devices manufacturer who has developed a glucometer that it wanted to launch in Japanese market.
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
