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Japan Drug GMP Requirements and Audits

Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. When a foreign drug company wants to register its drug in Japan, one of the most important steps is Japan GMP requirements. These GMP... Read More

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Japan’s Pharmaceuticals and Medical Devices Agency

Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. History and overview Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for supervising Japan’s medical regulatory procedures, conducting reviews of pharmaceutical and medical... Read More

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Japan GMP for Foreign Drug Manufacturers

Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug... Read More