Exceptional Science.
Uncompromising Quality.

Your regulatory compliant large molecule bioanalytical CRO

Custom Biologics is a global leader providing specialized, GLP-compliant, assay development, validation and testing services to support the pre-clinical/CMC and clinical stages of biopharmaceutical drug development.

Latest Resources

Event
February 25, 2025
WRIB (Workshops on Recent Issues in Bioanalysis) 2025
Join Custom Biologics at the 19th annual WRIB conference in New Orleans, April 7-11, 2025. Explore cutting-edge case studies in bioanalysis, biomarkers, and gene therapy and meet with our Head of Scientific Research & Innovation, Kalhari Silva. Book a meeting today.
Article
February 7, 2025
4 Pillars of a Robust Pharmaceutical Quality System (PQS)
Discover the 4 pillars of a robust Pharmaceutical Quality System (PQS) that ensures drug quality and regulatory compliance. Learn how implementing quality-driven processes, maintaining a clean and safe environment, fostering communication and transparency, and ensuring consistent quality across platforms help meet Health Canada and U.S. FDA standards for drug development.
Event
February 7, 2025
Biologics Conference & Workshop 2025: Biopharmaceutical Product Development
Join Custom Biologics at the 5th Annual Biologics Conference & Workshop in Goa, India, January 30-31, 2025. Learn about cell-based assays in biological drug development from our CEO, Dan Mamelak, Ph.D. Explore advanced techniques, case studies, and more.

Ready for the next stage of your drug development journey? Let’s plan next steps together.

Whether you have a specific project you’d like to discuss, or have a question about our suite of biopharmaceutical assays, we look forward to hearing from you.

Contact us today