Case Study 167 : Registration of Cosmetics in Japan
A global cosmetics company sought to enter ethe Japanese market by registering its cosmetic products in compliance with Japan’s regulatory framework. The objective was to ensure smooth market entry while adhering to the stringent requirements set by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).
Case Study 96: Marketing Authorization Transfer of Drugs in Japan
American pharmaceuticals company acquired the global right of inhaled drug product and needed to transfer the license of the product from the current marketing authorization holder to them. However , due to the fact that
• The company has no presence in Japan and were looking for a local MAH in Japan that can represent them and handle all MAT related activities and hold the license of the product on their behalf in Japan.
Case Study 165: Importation of Investigational Drugs for Clinical Trials in Mexico
A multinational pharmaceutical company sought to conduct clinical trials in Mexico and required the importation of investigational drugs. The company aimed
to leverage Mexico’s well established clinical research infrastructure and diverse patient population.
Case Study 102: Drug Distribution in Japan
A global pharmaceutical company aimed to streamline its drug distribution network in Japan. The objectives were to ensure compliance with Japan’s stringent regulatory standards under the pharmaceutical and medical device
act (PMDA), enhance supply chain efficiency, and improve product availability across the country. The company faced challenges, including complex local regulation, high operational cost, and the need to ensure product integrity during transit.
Case Study 116: RA Strategy for Quasi-Drugs in Japan
A multinational American manufacturer of health, beauty, and home care products was looking for a local partner in Japan who can provide the regulatory strategy for the registration of new oral care product in Japan.
Case Study 162: Registration of Class III Surgical Implant Medical Device in Japan
Client is a German medical device manufacture of surgical implants who needs support from local MAH for consultation meeting with PMDA.