When analytical methods must stand up to stringent CGMP regulations, no CRO beats ABC's combination of experience, responsiveness and regulatory performance.
Our breadth of experience and expertise ensures more than reliable data. We have the in-house analytical and drug development knowledge required to advise you on what type and how much information you need to move your program forward. This helps ensure the most economical, phase-appropriate approach to accomplish your development goals.
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.
When you visit ABC Laboratories, you will find a modern, CGMP-compliant facility and Standard Operating Procedures that strictly adhere to current FDA guidance. Our scientists and QA professionals work according to well-defined business processes that promote continuous quality improvement, timely delivery and transparent communication.