- ARE YOU SEEKING GOOD PRACTICE WITH A PARTNER TO MOVE YOUR CLINICAL PROJECTS FORWARD? RPM HAS THE ANSWER.
As the Marketing Authorization Holder (MAH) for pharmaceuticals in Japan, RPM provides end-to-end services seamlessly, from the early stage of planning throughout the completion of clinical study, including CTD preparation, GCP inspection, Phase IV study, and post-marketing surveillance (PMS) in response to regulatory requirements. We support not only world-class pharma, but also boutique biotech and venture companies who are unfamiliar with clinical settings and/or regulations unique to Japan. RPM advisors can help you to explore conceivable ways to gain a foothold for your business in Japan, such as team building (hiring or outsourcing) and/or consulting for planned studies, on a contract basis. Country-specific regulatory matters may also be critical, and RPM can stay with you.