Medicinal Chemistry
Compound Screening
DMPK
Safety & Toxicology
Bioanalytical
CMC
Medical Writing
Clinical Monitoring
Regulatory Affairs
Data Management and Statistical Analysis
Clinical Development Strategy
Site Management (SMO)
Subject Recruitment
Medical Device / IVD
Multi-region Clinical Trial (MRCT)
Vaccine Clinical Trial
Integrated Capabilities
GMP Consulting
Help you establishing a qualified GMP center to deliver treatment to patient.
Global GMP and Regulatory Compliance
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”
EU inspections
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
Factory Compliance
Laboratory Quality System Compliance
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