Developing and validating bioanalytical testing methods is often required to support clinical research from pre-clinical/early clinical development studies through Phase III trials.
We have extensive experience in bioanalytical method development and validation to meet your needs in compliance with GLP, Health Canada, and U.S. FDA guidelines. Our bioanalytical R&D team focuses on developing methods with an appropriate Lower Limit of Quantitation (LOQ) and swift turnaround periods. With over 30 validated methods and the capacity to develop custom assays, our team unfailingly provides the best possible analysis in the shortest time. Every step of the way, our activities are conducted in full compliance with regulatory standards.
Our bioanalytical testing services include:
- Assay method development, validation and transfers
- Expertise in many proven validated methods to quantitatively measure all types of compounds, small or large molecule, using:
- HPLC - GFC
- UPLC—UV, Fl, ECD
- Capillary Electrophoresis (CE)
- ELISA (Immunochemistry)
- Gel Image Analysis System
- Feasibility assessments
- Metabolite identification using LC/MS/MS
- Pre-clinical and clinical bioanalysis
Learn how we can help you conduct, develop, and validate bioanalytical test methods to support your research goals.