Accelerating your project with method expertise
For over 50 years, Regis has been a premier custom small molecule manufacturer with excellent analytical support services. Regis’ analytical capabilities are now available to customers requiring stand alone pharmaceutical services. Our Analytical Method Development team (AMD) consists of highly skilled analytical chemists talented in developing and validating phase appropriate methods. Let Regis help support your analytical requirements from pre-clinical R&D through clinical development, and into commercial manufacturing.
Pharma Services Offerings:
Method development
cGMP Method validations (phase appropriate)
Stability studies (Per ICH)
Release testing
Raw material testing
Reference standard characterization/qualification
Chiral purity/optical rotation
Residual solvents testing
Moisture content- Karl Fischer (volumetric and coulometirc)
Forced degradation studies
Preparative separations- SFC
Genotoxic impurity ID
Impurities characterization/isolation
Structural elucidation