Regulatory Services in Japan, Regulatory Services

Regulatory services in Japan for the pharmaceutical industry are essential for ensuring compliance with the country's stringent regulatory requirements. These services help pharmaceutical companies navigate the process of drug approval, including the submission of New Drug Applications (NDAs) and Clinical Trial Applications (CTAs) to the Pharmaceuticals and Medical Devices Agency (PMDA). They also assist with regulatory consultations, labeling compliance, and post-market surveillance. Japan’s unique regulatory framework demands expertise in local guidelines, which professional regulatory services provide to facilitate faster market access. Additionally, these services ensure adherence to the Japanese Pharmaceutical and Medical Device Act (PMD Act) and other local regulations.