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.
Case Study 161: Product Registration & Market Access for psoriasis treatment in Japan
European pharmaceutical company that intended to commercially launch in Japan an aqueous cream to treat psoriasis.
Case Study 159: Covid-19 Registration and Clinical Trials in Japan
The Client was in the process of commercializing its new developed oral fluid based covid-19 rapid antigen test in global markets.
Case Study 65: Pharmacovigilance Services: Clinical Safety in Japan
The Client is a multinational pharmaceutical company conducting a clinical study in Japan for an oncology product was looking for a local PV service provider who ha
Case Study 155: JNDA Submission for Radiopharmaceutical Product to PMDA
Client is a global manufacturer of radiopharmaceuticals used for diagnosis and treatment of cancers interested in Japan’s market.