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

Services

GxP

ServicesMultination MAH/MAAGxP

In the context of global regulations, companies in pharmaceutical, medical device, and cosmetics industries must ensure compliance across the entire supply chain and product lifecycle. This encompasses GxP requirements such as GMP (manufacturing), GDP (distribution), GSP (storage), GVP (vigilance), and GLP (laboratory). However, companies commonly face challenges such as shortage of specialized teams, complex differences in multinational regulations, and insufficient supply chain transparency.

As a professional compliance service provider, gempex offers comprehensive GxP services covering the entire lifecycle of pharmaceutical products. We not only provide GMP support but also extend our services to manifold regulations such as GDP, GSP, GVP, and GLP, empowering companies to build efficient, compliant, and traceable quality management systems.

Service Advantage

Comprehensive service
We provide GxP compliance services throughout the entire lifecycle, from research and development to post-market surveillance, meeting all types of compliance needs of companies as one-stop solutions.

Experienced expert team
Our team includes GxP experts from various fields, with extensive international compliance experience and well-versed with regulatory requirements in China, EU, USA and other countries.

Customized solutions
We provide practical and feasible compliance solutions based on company scale, development stage, and target markets to ensure effective compliance investment.

Continuous support
We offer comprehensive service support from system establishment to daily maintenance, ensuring continuous improvement and effective operation of quality management systems.

Alignment with international standards
We assist companies in establishing quality management systems that align with international standards, laying a solid foundation for global market access.

advantage

Service Scope

1. GDP services

  • We develop SOPs that meet international standards;
  • We conduct supplier audits.


2. GSP services

  • We establish a GSP system to ensure compliance throughout the entire business process;
  • We perform GSP-related qualification and validation services;
  • We provide support in reviewing documents related to warehousing.


3. GVP service

  • EWe establish vigilance systems and prepare corresponding SOPs.


4. GLP service

  • We provide GLP audit support, gap analysis, and laboratory data integrity training.