Case Study 155: JNDA Submission for Radiopharmaceutical Product to PMDA

Company Situation

Client is a global manufacturer of radiopharmaceuticals used for diagnosis and treatment of cancers. Considering Japan’s interest in using isotopes for indications of prostrate cancer, the client was seeking a strategic partner with experience in registering radiopharmaceuticals in Japan.

GRP Solution

GRP is among leading regulatory and clinical strategy and services providers with experience in commercialization of radiopharmaceuticals in Japan among other countries. GRP, using its experience helping market leaders in radiopharmaceutical industry provided a precise strategy for the Client to commercialize their products in Japan. The strategy was translated into phase-wise regulatory process in line with PMDA’s compliance requirements for successful commercialization of client’s products in the market.

Press Release: Announcement of Strategic Alliance and Partnership Agreement Between Micron, Inc and Global Regulatory Partners, Inc

Tokyo, Japan- 10 May 2022, Micron, Inc, a Japan-based CRO leader in Imaging and clinical trials, and Global Regulatory Partners Inc, a leading provider of clinical development, regulatory affairs and compliance services for the Pharma, Biotech and MedTech industries worldwide,

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