Integrated Capabilities

GMP Consulting

Help you establishing a qualified GMP center to deliver treatment to patient.

Global GMP and Regulatory Compliance

With 24 years of experience and proven track record of guiding customers through GMP guidelines, we understand how to establish a qualified GMP center in an efficient way. As a leader in GMP compliance consulting, we offer a full range of services in GMP compliance from development through commercialization, and help you design or adapt your quality and safety processes to minimize the risks involved in (bio) pharmaceutical production.

We provide comprehensive consulting services to ensure US cGMP, EU-GMP, WHO GMP and Chinese GMP compliance. Our services cover the entire life cycle of the GMP regulatory system.

GMP compliance cases globally, incl. 120+ cases for EU/FDA/TGA inspections
600+
Global customers & partners
1,000+
Medical consulting service
24   
Consulting experts in EU, US and China
30+

Proven Track Record

50+

FDA inspections, including 10 cases passed with “Zero deficiency”

50+

EU inspections

15

NMPA overseas inspections

10+

Australia TGA inspections

A Trusted Partner for GMP Consulting

Many of our consultants are industry pharmacists and specialists who are familiar with the applicable quality standards and can help you design or adapt your quality and safety processes in order to minimize the risks involved in biopharmaceutical production.

  • GMP Compliance (China and Overseas)

  • GMP Auditing – Mock Inspections

  • Factory Compliance

  • Laboratory Quality System Compliance

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