Quality system design belongs to top-level design, and the Quality by Design (QbD) philosophy also applies to the system itself. For a new established company, or a restructured enterprise, especially a multi-organizational, cross-functional enterprise or group, a good design can not only efficiently meet regulatory requirements, but also optimally allocate resources. Today, under the promotion of the MAH system, the management of quality-related activities becomes more flexible.
With rich project experiences and professional GMP knowledge, gempex can provide quality management system establishment strategies according to a company's future development, product portfolio and market planning.
Global rich projects experience
Coverage of multi-field customers (chemical drugs, biological drugs, raw materials and packing materials, medical devices, etc.)
Technical consultants with many years of experience in the quality department of pharmaceutical companies
1. Company organizational structure design
2. Function allocation and personnel qualification requirements
3. Quality management system models
4. Quality management documents listing, etc.
