Thursday, March 11, 2010     Login
SERVICES » Pharmaceutical Development » MDEV CMC
The ABC Difference

 

Pharmaceutical Development

Biotech Services-Recently Expanded!

DMPK and Bioanalytical Solutions (GLP)
Method Development & Validation
In-vitro DMPK Services
In-vivo DMPK Services
Bioanalytical Testing

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

Drug Development Consulting

Environmental Assessments

Seamless Project Management
through Strategic Partnerships

Method Development & Validation

When analytical methods must stand up to stringent CGMP regulations, no CRO beats ABC's combination of experience, responsiveness and regulatory performance. Our CGMP chemists have developed and validated thousands of proprietary, in-process and stability-indicating methods for assay of raw materials, API and drug product. ABC Laboratories has established an excellent reputation for our ability to reliably isolate, identify and quantitate impurities and degradants in API and across all dosage forms.

CGMP Method Development

Our scientists have extensive experience with a variety of HPLC techniques, as well as expertise employing Time of Flight (TOF-MS) and a variety of other sophisticated instrumentation.