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SERVICES » Pharmaceutical Development » MDEV
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

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Bioanalytical Method Development

ABC's bioanalytical team has developed and validated over 150 proprietary methods for preclinical and clinical programs, and has experience with 25 drug classes and across every biological matrix. Our approach to method development combines ingenuity with proven scientific practice, applying extensive experience in HPLC-UV, LC-MS/MS, as well as ELISA and RIA techniques to deliver sensitive methods with the lower limit of quantitation (LLOQ).

When you visit ABC Laboratories, you will find a modern, GLP-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.

Active participants in Crystal City meetings and technical discussion groups, our bioanalytical scientists deliver methods that are reliable, repeatable and robust.

Methods Experience

  

Expert Methods Develoment

Active participants in Crystal City meetings and technical discussion groups, our bioanalytical scientists deliver methods that are reliable, repeatable and robust.