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

Services

Inspection Support

ServicesMultination MAH/MAAInspection Support

Under the MAH system, enterprises that have obtained B certificate are required to undergo official on-site inspections. However, due to insufficient inspection experience and immature system operation, most enterprises face high-risk challenges. The drug regulatory authorities are increasingly strict with the requirements for commissioned production. The Cases of "joint punishment" for B and C certificates due to unqualified inspections of centrally-procured selected drugs occur frequently. Therefore, if enterprises are not fully prepared, they may face significant losses such as suspension of production and cancellation of centrally-procured qualifications.

gempex can provide professional support services for multi-country MAH/MAA inspections, with a deep understanding of the core logic and response strategies for inspections. We can help you confidently handle on-site inspections conducted by major global drug regulatory authorities (such as NMPA, FDA, EMA, etc.), effectively manage inspection risks, increase the chances of passing, and ensure the successful launch of your product.

Service Advantage

Integrated services
We provide full-process services, ranging from system establishment and license application to inspection support. This continuity ensures that we can provide more precise and efficient inspection support based on our in-depth understanding of the enterprise's situation.

Professional team
We are familiar with the key points and procedures of the B-certificate review conducted by the drug regulatory authority, and can assist enterprises in making sufficient preparations in advance to improve the pass rate of inspections.

International background
German, Switzerland, and Chinese teams + American partners, with a deep understanding of MAH/MAA regulatory requirements in China, Europe, and the United States, as well as familiarity with Chinese drug regulatory requirements and a deep understanding of international GMP standards.

Rich audit experience
The team possesses extensive domestic and international audit experience, is familiar with the characteristics and operational modes of quality systems in various types of enterprises, and is able to quickly identify weaknesses in enterprise systems. They can provide targeted improvement suggestions to help enterprises enhance their ability to prepare for inspections.

Successful MAH experience
We have served multiple enterprises in their MAH projects and assisted them in successfully obtaining production licenses.

advantage

Service Scope

Our services focus on the key links before and after the inspection, providing you with practical support:


1. Preparation before inspection

Review quality agreements, production records, deviation handling reports, and other documents, provide pre-inspection training, conduct full-scenario drills according to official inspection procedures, and help enterprises fully prepare for the inspection.


2. Support during inspection

  • Preparation of post-examination materials: Assist you in scientifically organizing and preparing all documents and records required by the examiner, ensuring timely and accurate responses.
  • On-site coordination and communication: As your technical backup, we assist in understanding and responding to inquiries from prosecutors, providing professional communication advice.


3. Post-inspection rectification

Assist you in accurately understanding the defective items, and guide you in formulating a rectification plan and response.