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

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.
Event
February 7, 2025
JPM Annual Healthcare Conference & Biotech Showcase 2025
Join us at the J.P. Morgan Annual Healthcare Conference and Biotech Showcase in San Francisco, January 13-16, 2025! Meet with our CEO, Dan Mamelak, to discuss drug development and bioanalytical needs. Book your meeting today before our schedule fills up!

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