gempex GMP Consulting
We provide customized solutions
gempex GMP Consulting
The compliance expert in life science

About gempex

gempex GmbH is an independent, international service provider specializing in consultancy and the implementation of GMP requirements in the life science industry. Founded in 2002 in Mannheim, Germany, gempex also has branches in Sisseln Switzerland, Guangzhou and Suzhou China. With our rigorous and professional services, gempex has won the trust of our customers. Until now, we have successfully managed over 5,000 global projects in the fields of pharmaceutical, API, biotechnology, raw materials and packaging materials, medical devices, cosmetics and other application.
  • 22+

    Foundation in Germany in 2002

  • 150+

    Our global annual number of customers

  • 300+

    Our global cooperation projects per year

  • 5000+

    Total executed global projects

Our Services

  • Global Compliance

    Over 20 years GMP service experience, providing compliance consulting services with EU, US, China, WHO, TGA and PIC/S etc.

    Over 20 years GMP service experience, providing compliance consulting services with EU, US, China, WHO, TGA and PIC/S etc.

  • New Facilities

    Q & V concepts to cover the entire life cycle of drugs, efficient and enforceable to meet the requirements of Q & V at all stages.

    Q & V concepts to cover the entire life cycle of drugs, efficient and enforceable to meet the requirements of Q & V at all stages.

  • Computerized System

    According to the computerized system life cycle model, provide CS management system and CS validation in accordance with GxP regulations

    According to the computerized system life cycle model, provide CS management system and CS validation in accordance with GxP regulations

  • Plant QMS

    Comply with the requirements of GxP regulations, providing quality management strategy consultation, customized establishment system documents, support the effective operation of quality management

    Comply with the requirements of GxP regulations, providing quality management strategy consultation, customized establishment system documents, support the effective operation of quality management

  • Multination MAH/MAA

    Reliable external quality team, including MAH system establishment, production license application and inspection support, MAH quality system management and operation

    Reliable external quality team, including MAH system establishment, production license application and inspection support, MAH quality system management and operation

Global Compliance

Over 20 years GMP service experience, providing compliance consulting services with EU, US, China, WHO, TGA and PIC/S etc.

New Facilities

Q & V concepts to cover the entire life cycle of drugs, efficient and enforceable to meet the requirements of Q & V at all stages.

Computerized System

According to the computerized system life cycle model, provide CS management system and CS validation in accordance with GxP regulations

Plant QMS

Comply with the requirements of GxP regulations, providing quality management strategy consultation, customized establishment system documents, support the effective operation of quality management

Multination MAH/MAA

Reliable external quality team, including MAH system establishment, production license application and inspection support, MAH quality system management and operation

Application Fields

    Pharmaceutical
    Biotechnology
    API
    Medical Devices
    Raw Materials and Packages
    Cosmetics
Pharmaceutical
Biotechnology
API
Medical Devices
Raw Materials and Packages
Cosmetics