IND for Global Nanomedicine company ($153+M) in US FDA
Case Study: End to End IND Strategy and Implementation Support for
Head and Neck Cancer Program
Registration of Software as Device in Japan and Australia
Company Situation Client had product registered in EU and was seeking to expand its presence in Asia-Pacific and LATAM countries in a phased manner. Client
Regulatory Strategy & Registration of Otometric Devices in Japan for a European Device Manufacturer
Company Situation Client was new to Japan market and needed end to end support right from strategy, product registration, legal representation, marketing authorization holder in
Regulatory Strategy for Registration of a Class I Wearable Pain Relief Device and Software in Japan
Company Situation Client is a global CRO that was in process of registering a wearable class I pain relief device along with a mobile app
Regulatory Strategy, Clinical Trials and Registration of Class III Dermal Filler in China
Company Situation The Client is a manufacturer of innovator devices based on laser, ultrasound, light and radiofrequency for aesthetics and surgical markets. Client has devices
Expansion into Japan, Australia and Brazil for American based Medical Device Company
Company Situation The Client had developed novel devices for multiple applications including for dermatology, cosmetics, plastic surgery and aesthetics. The products already had CE marking
