cGMP Syn

Pharmaceutical Development

Radiolabeling & Synthesis Solutions
non-GMP Services
CGMP Services
Phase 0 Development Support

CMC & QC Solutions (CGMP)
Method Development & Validation
Extractables/Leachables Studies
Trace Analysis & Structural Chemistry
Stability Programs and Release Testing

Environmental Assessments

Regulatory Consulting

Seamless Project Management
through Strategic Partnerships

CGMP Radiolabeling & Synthesis

Few contract research laboratories maintain the rigorous CGMP-compliant environment required to produce certified radiolabeled product suitable for human clinical trials. ABC Laboratories maintains four Class 10,000 CGMP Synthesis suites, a dedicated Quality Assurance staff and a group of analytical chemists with years of experience supporting labeled isotope studies. This unique capability complements in-house drug metabolism and impurity ID expertise and streamlines project management.

Early Clinical Support

GMP API suitable for early clinical trials
Radiolabeled (¹⁴C) GMP API for early clinical trials
Radiolabeled (¹⁴C) GMP drug product formulations
Analytical support dedicated to synthesis activities
- Method development and early phase validation
- Certificate of analysis generation

ABC Laboratories is one of the few contract research laboratories with a separate CGMP synthesis suite that can produce radiolabeled CGMP product, complete with batch records and Certificates of Analysis.