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

THE GMP EXPERT
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The compliance expert in life science
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About gempex

gempex China, a wholly-owned subsidiary of gempex in China, is an internationally influential GMP consultancy and implementation company, committed to providing compliant, efficient and executable GMP solutions for global life science enterprises. We have a team of over 60 experienced GMP experts and are well-versed in GMP requirements from the NMPA, FDA, EU, WHO, ICH, PIC/S, MHRA, SWISSMEDIC and TGA. This enables us to provide customized solutions for clients from different nations and regions, including global GMP compliance, new facility compliance, computerized system validation (CS), plant QMS, and multination MAH/MAA services.
  • 22+

    GMP Experiences

  • 5000+

    Global Projects

  • 1000+

    Global Clients

  • 460+

    China Projects

  • 20+

    Countries

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

Join gempex — Start Your Professional Career with Us

At gempex, we attach great importance to personal career development. Open and transparent corporate culture and clear talent development channels provide career development space for every employee.

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News Center

2024-05-24
Creative Collisions, Ceramic Art Journey: Account of the Team-Building Activity on May 23rd in China

gempex team building- "Ceramic Art Journey"

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2023-10-30
gempex new webpage GMP Knowledge officially launched

gempex GMP Consulting has established a GMP technical article resource tool – GMP Knowledge, mainly concluding the experience of gempex experts in the GMP consulting and execution. In order to bring you more GMP knowledge and reading experience, g

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2023-08-31
gempex invites you to attend the Conference on China Drug Quality Safety in Guangzhou

gempex will participate in the 14th (2023) Conference on China Drug Quality Safety on September 15-16, 2023 in Guangzhou. Our booth number is A25.

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2023-08-30
2023 US FDA cGMP Inspection will be Further Intensified

On July 18, 2023, US FDA was questioned about inadequate inspections in India and China.

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