Marketing Authorization Holder (MAH) system has brought new opportunities to the pharmaceutical industry. It allows the holder to proceed outsourcing production, at the same time emphasizes that the holder is fully responsible for the whole life cycle of the drugs. As always, opportunities and challenges co-exist! It is required that MAH should establish complete organizational structure and management system, as well comprehensively supervise the activities of each suppliers, all in all, to ensure the safety, effectiveness and quality controllability of the products. These requirements are challenges for the MAHs, especially for those startups, R&D institutions and researchers.
gempex can provide MAH outsourcing services. We provide accompanying services along our customer business development, supporting for solving the above problems faced by enterprises. gempex can provide MAH support and assistance in manpower and technology for enterprises, and ensure your business success!