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

Services

GxP Service

ServicesMultination MAH/MAAGxP Service

In the context of globalized regulation, enterprises in some industries, such as pharmaceuticals, medical devices, and cosmetics, should ensure compliance across the entire supply chain and throughout the product lifecycle, encompassing GxP requirements such as GMP (manufacturing), GDP (distribution), GSP (supply), GVP (vigilance), and GLP (laboratory). However, enterprises generally face challenges such as a shortage of professional teams, complex differences in cross-border regulations, and insufficient transparency in the supply chain.

As a professional compliance service provider, gempex offers GxP services encompassing the entire lifecycle of pharmaceutical products. We not only provide GMP support but also extend our services to areas such as GDP, GSP, GVP, and GLP, assisting enterprises in building an efficient, compliant, and traceable quality management system.

Service Advantage

Comprehensive service coverage: We provide GxP compliance services throughout the entire lifecycle, from research and development to post-market surveillance, meeting all types of compliance needs for enterprises in a one-stop manner.

Experienced expert team: Comprising GxP experts from multiple fields, with extensive international compliance experience and familiarity with regulatory requirements in China, EU, USA and other countries.

Customized solutions: Provide practical and feasible compliance solutions based on the size, development stage, and target market of the enterprise, ensuring the effectiveness of compliance investment.

Continuous support: Provide comprehensive service support from system establishment to routine maintenance, ensuring continuous improvement and effective operation of the quality management system.

Alignment with international standards: Assist enterprises in establishing a quality management system that aligns with international standards, laying a solid foundation for products to enter the global market.

advantage

Service Scope

1. GDP services

  • Develop SOPs that meet international standards;
  • Provide support for supplier audit services.


2. GSP services

  • Establish a GSP system to ensure compliance throughout the entire business process;
  • Perform GSP-related qualification and validation services;
  • Provide support for reviewing documents related to warehousing.


3. GVP service

  • Establish a drug vigilance system and draft corresponding SOPs.


4. GLP service

  • Provide GLP audit support, gap analysis, and training on laboratory data integrity.