Case Study 21 : Regulatory Strategy & Registration of Otometric Devices in Japan
The Client is a European medical device company, leader in the design and manufacture of otoscopes and audiometric products.
Case Study 20 : Regulatory Intelligence Report on New Medical Device Market Access to Japan
Client had a novel technology induced medical devices which they wanted to launch in Japan. They wanted support regarding the category and the registration process for such products.
Case Study 19 : Renewal of Foreign Manufacturer Accreditation (FMA/FMR) in Japan
A US based Medical Device company leader in the development and manufacture of surgical medical devices, had to renew urgently the FMA (Foreign Manufacturing Site accreditation) certificate
Case Study 18 : Regulatory Strategy & Registration of medical devices in Japan
Client was new to Japan market and needed end to end support right from strategy, product registration, legal representation, marketing authorization holder in country
Case Study 17 : Pharmacovigilance Services for CRO in Japan
The Client is a is a Japanese CRO that is conducting a phase III clinical study in Japan for a Software medical device ( Class III)
Case Study 15 : Regulatory Strategy & Registration of Medical Device in Japan
Client was new to Japan’s market needed end to end regulatoy support from regulatoy strategy & product registration