CMC & QA Consulting Support

Advantar follows current Good Manufacturing Practices (cGMP) for clinical-stage projects, encompassing analytical development and validation, preformulation and formulation development, method remediation and stability studies. cGMP’s are fundamental to the Quality Systems that control the overall manufacturing and analysis of drug substances and drug products as well as medical diagnostics and medical devices critical in the monitoring and compliance with established quality/safety requirements made by regulatory bodies from around the world.

Licenses/Registrations

DEA Controlled Substance Registration: RAO385307

EPA ID: CAL000348851

FDB Drug Manufacturing License: 52818

FDA Registration: 849636258