Services
Bioanalytical Expertise
Experience with in diverse bioanalytical assays (bioanalysis, immunogenicity, biomarkers) for small and large. Offers troubleshooting, GxP validation, and comprehensive documentation reviews
- Assay format selection (bioanalysis, immunogenicity, biomarker)
- Therapeutic types:
- Small molecules
- Liposomal formulations
- Antibodies (monoclonal, bispecific, ADCs)
- Proteins
- Peptides
- Enzymes
- DNA- and RNA-based drugs
- Assay troubleshooting (LC-MS/MS, LBA, ECL, cell-based NAb)
- GxP Validation and fit-for-purpose qualification of assays used in toxicology and clinical studies
- Review bioanalytical sections of toxicology and clinical protocols, laboratory manuals
- Review of protocols, reports, and data from individual studies
- Prospective and data review audits of bioanalytical vendors
- Evaluate and author SOPs
Project Management and Logistics
Evaluates and selects bioanalytical CROs, manages proposals, reviews project scope and budgets, oversees CRO management and timelines, develops lab manuals, and ensures proper clinical sample handling and analysis processes.
- Bioanalytical CRO evaluation and selection
- Proposal requests with appropriate project scope and budget review
- CRO management and timeline oversight
- Lab manual development
- Clinical sample shipments and batching for sample analysis
- Data transfer agreements
- Review and approve protocols, reports, deviations, investigations, etc.
Strategy
Assess existing bioanalytical reports and assay performance for regulatory compliance, evaluate programs to determine appropriate strategy for different development stages, and review laboratory processes for compliance and growth.
- Review existing bioanalytical reports and assay performance for regulatory gaps
- Evaluate programs to determine assays needed to support various stages of development
- Evaluate bioanalytical laboratory processes and procedures for compliance and growth
