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

Services

Inspection Support

ServicesMultination MAH/MAAInspection Support

Under the MAH system, companies are required to undergo official on-site inspections after having obtained class B certificate. However, due to limited inspection experience and immature system operation, most companies face high-risk challenges. Drug regulatory authorities are increasingly strict with the requirements on contract manufacturing. The cases of "joint punishment" for class B and C certificates due to failed inspections of selected centrally procured products occur frequently. Therefore, if companies are not fully prepared, they may face significant losses such as suspension of production and cancellation of centrally procured qualifications.

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

Service Advantage

Full comprehensive services
We provide full services for the entire process, ranging from the establishment of a quality management system and license application to inspection support. This continuity ensures that we provide more precise and efficient inspection support based on our in-depth understanding of the company’s situation.

Expert team
We are well-versed with the key points and procedures of the class B-certificate reviews conducted by drug regulatory authorities, and assist companies prepare thoroughly in advance to increase inspection pass rates.

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

Extensive audit experience
The team brings substantial domestic and international audit experience, is familiar with the characteristics and operational modes of quality systems in various types of companies and industries. We quickly identify weaknesses in companies’ quality systems and provide targeted improvement recommendations to help companies enhance their ability to prepare for inspections.

Proven MAH success
We have served multiple companies through their MAH projects and assisted them in successfully obtaining MAH licenses.

advantage

Service Scope

Our services focus on the critical stages before, during and after inspections, providing you with practical support:


1. Preparation before inspection

We review quality agreements, production records, deviation handling reports, and other documents required. We provide inspection training, conduct full-scenario drills following authorities’ inspection approach, and help companies fully prepare for the inspection.


2. Support during inspection

  • Preparation of inspection materials: We assist you in systematically organizing and preparing all documents and records required by the authority, ensuring timely and accurate responses during the inspection.
  • On-site coordination and communication: As your technical backup, we assist in understanding and responding to inspector inquiries providing experienced communication support and guidance.


3. Support after inspection

We assist you in accurately interpreting non-conformities and guide you in preparing corrective action plans and responses.

Service Workflow