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CMC and QC Solutions (CGMP)
Phase-appropriate Development Expertise

When it comes to Chemistry Manufacturing and Controls (CMC) aspects of drug development, no CRO beats ABC's combination of experience, responsiveness and regulatory performance. We deliver expert CMC analytical support and Quality Control for API and drug product across most dosage forms, and have the in-house expertise required to advise you on what type and how much information you need to achieve your development goals in the most economical, phase-appropriate manner.

Our CMC team includes niche expertise in method development, stability and batch release, structural chemistry, extractable and leachables, and impurity identification. We've earned a reputation for our ability to reliably isolate, identify and quantitate impurities and degradants in API and across all dosage forms. So no matter what your development challenge, ABC has the in-house CMC expertise to efficiently move you to your next development milestone.

Best Practices in Current Good Manufacturing Practice

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 deliver and transparent communication.

click here to download CGMP Regulatory Guidance