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.
Case Study 156: Registration of DMF in Japan for COVID-19 Vaccine
The client has developed a new drug, class 1 new chemical drug as per classification in China and was planning to submit the IND in China.
Case Study 122: Application for New Foreign Manufacturer Accreditation (FMA/FMR)
The client is a European pharmaceutical company with no presence in Japanese market but has to conduct local clinical studies with PMDA.