Culture & Values
Subsidiaries & Joint Ventures
Diversity & Inclusion
Sustainability & ESG Report
Safety & Toxicology
Data Management and Statistical Analysis
Clinical Development Strategy
Decentralized Clinical Trials (DCTs)
Site Management (SMO)
Medical Device / IVD
Multi-region Clinical Trial (MRCT)
Vaccine Clinical Trial
Functional Service Provider (FSP)
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.
Proven Track Record
FDA inspections, including 10 cases passed with “Zero deficiency”
NMPA overseas inspections
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
Laboratory Quality System Compliance