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SERVICES » Pharma Svcs » MDEV CMC

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 utilizing Time of Flight (TOF-MS) and a variety of other sophisticated instrumentation.