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

Services

QMS Upgrade

ServicesPlant QMSQMS Upgrade

Establishing and maintaining a controlled, traceable, and continuously improving QMS system is a core task for enterprises in the life sciences sector throughout the entire product lifecycle. In the current context of the dual circulation strategy of "import + export" and the comprehensive implementation of the MAH system, the ever-changing and high-demand regulatory environment necessitates that QMS must become a "living system" that maintains high adaptability and effectiveness. Only through continuous improvement can we effectively cope with systemic risks arising from tightening regulations, cross-border compliance, and the amplification of principal responsibility in the global market.

As an international GMP consulting and execution supplier, gempex has extensive experience in QMS upgrade. Through professional compliance diagnosis and one-stop system enhancement services, we assist enterprises in building a quality management system that not only meets global compliance requirements but also supports business development.

Service Advantage

Multinational Compliance System
Our team comprises regulatory experts from multiple regions including China, USA, and EU, offering bilingual support in Chinese and English. It can simultaneously meet GMP requirements in China, EU, USA, and other regions, assisting enterprises in building a unified and compatible quality management system, and supporting market access both domestically and internationally.

Customized service
Based on the actual situation and needs of the enterprise, we provide tailored system optimization solutions to ensure practicality and feasibility.

Rich audit experience
We possess extensive audit experience in both domestic and foreign enterprises, are familiar with the operational characteristics of various systems, and are capable of accurately identifying weak links, introducing you to the best practices in the industry.

Multi-field and full-process coverage
With service experience in multiple fields such as biopharmaceuticals, chemical drugs, medical devices, raw materials and packages, we provide one-stop full-process services from early diagnosis to continuous tracking in the later stages.

Continuous optimization and maintance
We not only focus on project delivery, but also prioritize knowledge transfer and the sustainability of the system.

advantage

Service Scope

We offer one-stop upgrade services covering the entire lifecycle of QMS, precisely addressing the needs of enterprises at different stages of development:


  • Gap analysis
    Based on the regulations of target markets (NMPA, FDA, the EMA, etc.), systematically assess the compliance of the enterprise's existing QMS with international standards, identify systemic deficiencies and opportunities for improvement, and output a risk classification report and rectification suggestions.


  • Existing QMS optimization
    For the existing system, we provide integrated upgrade services ranging from quality policy, process optimization, document upgrading to execution reinforcement.
  • Establishment of a brand-new QMS system
    Providing QMS framework design and comprehensive system documentation services that meet international standards for newly established enterprises, MAH holders (B-license enterprises), or newly added production lines.


Service Workflow