Case Study 14 : Support for Change of In-Country Caretaker (ICC) in Japan for a European API company Client Situation
Client currently had an ICC in Japan and wanted to change it to another company with expertise in regulatory space. They reached out to GRP to act as their ICC and change from the current ICC to GRP.
Case Study 13 : New Drug Registration in USA, China and Japan
Client wanted to start the registration process in China and once approved in China they wanted to get registered in US and Japan in parallel.
Case Study 5 : Regulatory, Clinical and Commercial Partners For CE-IVD Device in Japan for IVD
Company Situation Client’s IVD product was classified as Class III in Japan and required a clinical trial to be done locally. There was no similar
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.
Case Study 4: Regulatory Strategy & Registration of Otometric Devices in Japan for a European Device Manufacturer
European medical device company needed end to end support from regulatory strategy, product registration, legal representation and MAH of product in Japan
Case Study 3: Regulatory Strategy for Registration of a Class I Wearable Pain Relief Device and Software in Japan
Client is a global CRO that was in process of registering a wearable class I pain relief device along with a mobile app in global markets.