• 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 China

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 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 (CS), plant QMS, and multination MAH/MAA services.
  • 24+

    GMP Experience

  • 5000+

    Global Projects

  • 1000+

    Global Clients

  • 540+

    China Projects

  • 20+

    Countries

Our Services

  • Global Market Expansion

    gempex Consulting leverages its multi-country regulatory expertise (China, U.S., Europe, etc.) and global resource network to provide pharmaceutical companies with a one-stop, end-to-end solution—from international access compliance to global supply chain.

    gempex Consulting leverages its multi-country regulatory expertise (China, U.S., Europe, etc.) and global resource network to provide pharmaceutical companies with a one-stop, end-to-end solution—from international access compliance to global supply chain.

  • Inspection Readiness

    gempex is familiar with the requirements of authority inspection and has accumulated years of practical experience, and can provide international inspection guidance and audit support for pharmaceutical and medical device enterprises.

    gempex is familiar with the requirements of authority inspection and has accumulated years of practical experience, and can provide international inspection guidance and audit support for pharmaceutical and medical device enterprises.

  • Facilities Validation

    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.

  • 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

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

  • CS&AI Compliance

  • More Consulting

Global Market Expansion

gempex Consulting leverages its multi-country regulatory expertise (China, U.S., Europe, etc.) and global resource network to provide pharmaceutical companies with a one-stop, end-to-end solution—from international access compliance to global supply chain.

Inspection Readiness

gempex is familiar with the requirements of authority inspection and has accumulated years of practical experience, and can provide international inspection guidance and audit support for pharmaceutical and medical device enterprises.

Facilities Validation

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

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

CS&AI Compliance

More Consulting

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

2026-04-17
MRKare Pharma's High-Potency API Facility Reaches Another Milestone: Passed NMPA Drug Registration On-Site Inspection

MRKare Pharma successfully passed the on-site inspection for new API product registration organized by the NMPA.

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2026-02-05
Asia-Pacific Leads in ATMP Clinical Trials, How Can Chinese Biotechs Seize the European Window?

Establish the key pathways for ATMP to enter the EU market.

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2026-01-14
Breaking Barriers in Global Expansion: gempex Consulting Partners with NextPharma to Offer a “One-Stop” Solution from Compliance to Supply

Break through the key path for Chinese biopharmaceuticals to enter the EU market.

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2025-11-27
On the Scene at the ECA Annual Forum: Deciphering New Trends in Pharmaceutical Compliance

Mr. Ralf, founder of Gempex Consulting, participated deeply in the annual forum, bringing the latest insights on global GMP compliance.

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