At XenoFinder, our biotransformation consulting services are designed to help pharmaceutical and biotech clients navigate the complex landscape of drug metabolism and ADME science. With deep scientific expertise and extensive hands-on experience, we provide strategic guidance that supports smarter drug design, development, and regulatory success.
What We Offer
Strategic Study Design
· Tailored recommendations for in vitro and in vivo biotransformation studies
· Guidance on appropriate species selection, time points, and matrices
· Integration of biotransformation considerations into your overall DMPK strategy
Metabolite Identification & Characterization
· Interpretation of LC-HRMS and radiodetection data
· Structural elucidation of metabolites
· Assessment of major and minor pathways, metabolic soft spots, and active metabolites
Regulatory Support
· Expert input on MIST (Metabolites in Safety Testing) compliance
· Support for IND, NDA, and global regulatory submissions
· Preparation or review of regulatory documents, summaries, and responses
Mechanistic Insight & Troubleshooting
· Mechanistic evaluation of unusual or unexpected metabolic pathways
· Root-cause analysis of metabolic liabilities or PK and PK/PD issues
New Modalities & Complex Compounds
· Biotransformation strategy for ADCs, peptides, oligonucleotides, and botanical drugs
· Specialized knowledge in handling hybrid molecules and novel conjugates
Collaborative Support
· Act as an external scientific advisor to your discovery or development team
·Participate in project team meetings, study reviews, or regulatory discussions