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

Services

Vendor/Supplier Management

ServicesMultination MAH/MAAVendor/Supplier Management

In the context of globalization, Marketing Authorization Holder (MAHs) must ensure compliance, reliability, and traceability across all supply chain stages, including manufacturing, warehousing, logistics, and testing. However, due to limited resources, difficulties in conducting cross-border audits, and the high complexity of international regulations, many companies struggle to effectively manage global supply chain compliance risks. This, in turn, often leads to product quality issues, failed regulatory inspections, delayed market launches, or even market bans.

Leveraging its deep expertise in international GMP compliance and multi-disciplinary expert teams, gempex provides MAH/MAA companies with supplier and service provider management solutions covering regulations such as the EU EMA, US FDA, and China NMPA. We assist companies in systematic assessing, auditing, and managing global supply chain compliance, ensuring supplier services meet target market regulatory requirements. This significantly reduces compliance risks and accelerates global market launch of products.

Service Advantage

International team
As a German-based company, gempex can quickly adapt to international regulations, providing seamless communication and reports in both languages, Chinese and English.

"On-site-like" audit report
We provide comprehensive, clearly structured audit reports, covering strenghts and areas for improvement, with proven templates that meet regulatory review requirements. 

Expert bridge
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.The gempex expert team provides regulatory backgrounds from at least China, EU, and USA, with deep understanding of the perspectives and needs of MAH/MAA and manufacturing companies. This effectively facilitates 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.Through remote auditing and local team coordination, we significantly reduce company’s cost and time investment for multinational 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.We have delivered supplier/service provider audits and compliance management services to nearly 100 global companies, covering various sectors such as biologics, pharmaceuticals, chemical excipients or active ingredients, and medical devices.

advantage

Service Scope

  • Supplier audit
We support document audits, remote audits, and on-site audits, and provide objective and comprehensive audit reports and recommendations for corrective actions.

  • Supplier document review
We conduct multi-regulatory reviews of technical documents, quality records and compliance certificates provided by suppliers, identify non-compliances and propose measures for improvement.

  • Quality agreement review
Based on duties of MAH and target market regulations , we develop responsibility strategies and review compliance aspects of agreements between both parties to ensure clear delineation of responsibilities and regulatory adherence.


Service Workflow