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 drugs life cycle according to regulations.
gempex technical experts can help companies establish system documents to meet the requirements of holders complying 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.
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
gempex can assist in identifying and analyzing MAH's quality activities and processes. We can assist the client to establish quality management systems, including pharmacovigilance management system, according to the client's situation and requirements, including:
If thecustomer already has some documents,gempex experts will integrate the established or already operating documents into the new system.Therefore,gempex services includeanalyze of existing system and integrate related information into the new MAH system.
