Ontario – Toronto GTA – Mississauga
Corporation
www.custombiologics.com
Ontario
Toronto GTA
Mississauga
Corporation
active
Operating name: Custom Biologics
Custom Biologicsâ„¢ provides specialized biopharmaceutical research services for drug development, proteomic biomarker discovery and biological product development.
Our drug development programs specialize in custom assays for pre-clinical, clinical and bioequivalency studies. Custom Biologicsâ„¢ adheres to a rigorous QA program in strict compliance with US FDA Guidance, 21 CFR Part 58. With an experienced staff of PhD-trained scientists, we have developed and validated sensitive bio-analytical methods for clients in Canada, US and Europe. We are able to accurately determine and quantify active drug and/or drug metabolite(s) in samples collected from plasma, urine, cell culture media, or other biological matrices from either humans or animals. Our technical expertise also extends to analytical protein and biomarker discovery.
Our established QA program complies with US FDA regulatory guidelines, 21 CFR Part 58. We operate a modern state-of-the-art research facility equipped with a backup power generator, freezer storage capacity (-20°C to -80°C), walk-in cold room, animal care facilities and dedicated cell culture suites.
We function as an extension of our clients€™ research and clinical development programs. All projects are completed in a cost-effective and timely manner.
Country of Ownership: Canada
Exporting: Yes
Primary Industry (NAICS): 541710 - Research and Development in the Physical, Engineering and Life Sciences
Primary Business Activity: Services
Services:
Bioanalytical research
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Profile ID: LFCA-COD-O-21125