• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Sponsor or MAH Qualification

ServicesGlobal Market ExpansionSponsor or MAH Qualification

National Medical Products Administration (NMPA) has publicly released the inspection points for pharmaceutical marketing authorization holder (MAH). The purpose is to further standardize the supervision and inspection of MAH as well as supervise the holders to fulfill the responsibility of quality management of the entire drug life cycle according to regulations.

gempex technical experts can help companies establish system documents to meet the requirements of holders complying with the MAH requirements, covering whole processes of management from R&D, clinical, manufacturing, supply and product retirement. Ensure the safety, effectiveness and quality control throughout the whole life cycle.

Service Advantage

Accompanying service along customer’s business development.

Compliance system covering whole processes of R&D, clinical, manufacturing and business.

Support many enterprises for MAH projects and with successfully obtaining production licenses.


advantage

Sponsor or MAH Qualification

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, 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!