Consulting Services
At BioAgilytix, we are at the forefront of drug development not just as a premier CRO service provider but also as thought leaders in the field of bioanalysis. We offer our expertise in building comprehensive bioanalytical packages for successful regulatory submissions at any stage of the drug development process.
Meet our Scientific Team
Our scientific leaders have decades of experience across the pharmaceutical and biotechnology industries including drug metabolism, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, CMC bioanalytical testing, and diagnostic testing. Learn more about each of our scientific officers who provide individualized consulting services for BioAgilytix here.
Technical Experts
As advisors for our internal scientific teams with previous hands-on experience leading assay development and sample analysis, our scientific officers are able to provide deep technical expertise across a range of consulting solutions including:
- Bioanalytical method development and validation
- Bioanalytical project management
- CRO selection and oversight
- Reagent generation and lifecycle planning
- CMC bioanalytical testing strategies
- Technology-specific consultation
Global Regulatory Experts
With locations in the EU, Australia, and the United States, BioAgilytix continually interacts with global regulatory agencies. Our scientific officers are available to provide consultation and drive strategies for meeting country-specific regulatory expectations for bioanalytical testing. Let our experts help you navigate:
- Designing phase-appropriate bioanalytical support packages
- Selecting necessary assay types and formats by therapeutic modality
- Using fit-for-purpose and context-of-use approaches
- Applying specific regulations such as CLIA and IVDR to assay design as needed
Partner with a Proven Leader in Bioanalysis
BioAgilytix maintains an exceptional regulatory track record and is focused on ensuring scientific integrity in everything that we do. Leverage our capabilities and expertise for your project through our consulting services. Our scientific officers are leaders in the field of bioanalysis who can proactively anticipate assay challenges and regulatory needs to help keep your program on track. Contact us today to see how we can work together to get your therapeutic successfully through to approval faster.
Speak to a scientist today
Learn more about how BioAgilytix can help you reach your discovery drug development goals