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

Services

Vendor/Supplier Management

ServicesMultination MAH/MAAVendor/Supplier Management

In the globalization, Marketing Authorization Holder (MAHs) must ensure compliance, reliability, and traceability across all aspects of the supply chain, including production, warehousing, logistics, and testing. However, due to issues such as limited resources, difficulties in conducting cross-border audits, and the high complexity of regulations, many companies find it challenging to effectively manage global supply chain compliance risks. This, in turn, can lead to product quality issues, regulatory inspection failures, delays in market launch, and even market bans.

gempex, leveraging its profound international GMP compliance background and multi-disciplinary expert team, provides MAH/MAA enterprises with supplier and service provider management solutions covering regulations such as the EU EMA, US FDA, and China NMPA. We assist enterprises in systematically assessing, auditing, and managing global supply chain compliance, ensuring that supplier services meet the regulatory requirements of target markets, significantly reducing compliance risks, and accelerating the global product launch process.

Service Advantage

International team
With a German background, our company possesses the ability to quickly adapt to international regulations, ensuring seamless communication and report output in both Chinese and English.

"On-site-like" audit report
Provide a comprehensive and clearly structured audit report, covering positive aspects and areas for improvement, with a rigorous template that meets regulatory review requirements.

Expert bridge role
The expert team possesses regulatory backgrounds from China, EU, and USA, and is familiar with the perspectives of MAH/MAA and manufacturing enterprises, effectively facilitating efficient communication and alignment of understanding between customers and suppliers.

Cost and efficiency optimization
By utilizing remote auditing and local team coordination, we can significantly reduce the cost and time investment for enterprises in cross-border auditing.

Practical experience
We have provided supplier/service provider audit and compliance management services to nearly 100 enterprises worldwide, covering multiple fields such as biologics, chemical drugs, and medical devices.

advantage

Service Scope

  • Supplier audit
Support document audit, remote audit, and on-site audit, and provide objective and comprehensive audit reports and rectification suggestions.

  • Supplier document review
Conduct multi-regulatory review of technical and quality documents, compliance certificates, etc. provided by suppliers, identify violations, and propose improvement suggestions.

  • Quality agreement review
Based on the responsibilities of the MAH and the regulations of the target market, develop a responsibility strategy, review the compliance of the agreement between both parties to ensure that responsibilities and rights are clear and meet regulatory requirements.