.
.
.
Bioanalytical Services
Introduction
At ResolveMass Laboratories Inc., our Bioanalytical Services empower biopharma and biotech organizations to generate accurate, reproducible, and regulatory-compliant data throughout their development processes. We excel in quantifying and characterizing diverse molecular entities — from small compounds and peptides to complex biomolecules and antibodies — through advanced LC-MS/MS and ligand-binding methodologies.
Our scientific experts leverage analytical experience alongside the latest mass spectrometry innovations to deliver data aligned with FDA, EMA, and Health Canada standards. From method development and validation to routine sample analysis, ResolveMass offers a fully integrated bioanalytical partnership defined by precision and dependability.
Learn more about our Bioanalytical Quantification expertise →
Our Core Bioanalytical Capabilities
Small Molecule Analysis
Validated LC-MS/MS assays provide high-sensitivity quantification for small molecules, metabolites, and related impurities.
Large Molecule Bioanalysis
Our hybrid LBA-MS systems deliver in-depth pharmacokinetic and immunogenicity assessments for monoclonal antibodies and peptides.
Biomarker Quantification
Comprehensive biomarker measurement using multiplexed LC-MS and immunoassay-based techniques.
Explore: Biomarker Quantification Services →
Why Choose ResolveMass Laboratories?
Scientific Expertise: PhD-level scientists with extensive knowledge in analytical chemistry and bioanalysis.
Regulatory Alignment: Every assay adheres to FDA, EMA, and ICH bioanalytical method validation standards.
Cutting-Edge Technology: Advanced LC-MS, QTOF, and high-resolution mass spectrometry systems for reliable analysis.
Customized Study Design: Tailored assay development addressing each molecule’s unique properties.
Quality and Integrity: ISO- and GLP-compliant operations ensuring data accuracy, reproducibility, and transparency.
See how to select the Best CRO for LC-MS analysis →
Our Bioanalytical Workflow
Consultation and Study Design – Collaborative planning to define project objectives and analytical requirements.
Method Development – Design of selective and sensitive assays for specific molecular structures.
Validation – Regulatory-compliant method validation confirming accuracy and precision.
Sample Analysis – High-throughput bioanalysis using established and verified procedures.
Data Review and Reporting – Comprehensive, audit-ready documentation prepared for regulatory submission.
Areas of Expertise
Therapeutic Proteins & Antibodies
Accurate quantification and immunogenicity testing of biologic drugs.
Peptides & Oligonucleotides
Targeted bioanalysis using stable isotope-labeled standards for enhanced reliability.
Pharmacokinetics (PK) & Pharmacodynamics (PD)
Complete PK/PD evaluations supporting both preclinical and clinical stages.
Biomarker Discovery & Validation
Comprehensive biomarker support from identification to validated clinical quantification.
Partner with Our Bioanalytical Experts
Conclusion
In summary, the Bioanalytical Services at ResolveMass Laboratories Inc. combine scientific precision, regulatory alignment, and advanced analytical instrumentation to support every stage of therapeutic development. From discovery through clinical validation, our experts deliver trustworthy data that drive confident, data-backed decisions.
Frequently Asked Questions
These services involve the quantitative evaluation of drugs, metabolites, and biomarkers within biological samples using LC-MS/MS and ligand-binding assays, ensuring reliable PK and PD data for development programs.
They verify the stability, reproducibility, and accuracy of therapeutic compounds — essential for regulatory compliance and patient safety.
Yes. All methods are developed and validated in accordance with GLP standards under FDA and EMA regulations.
Through rigorous quality controls, internal standards, and calibrated multi-level quantification protocols.
References
- Pawar, S. V., & Gaware, V. M. (2025). A review on: Bioanalytical method development and validation. Asian Journal of Pharmaceutical Research and Development, 13(3), 167-179. https://ajprd.com/index.php/journal/article/download/1578/1606
- Tijare, L. K., Rangari, N. T., & Mahajan, U. N. (2016). A review on bioanalytical method development and validation. Asian Journal of Pharmaceutical and Clinical Research, 9(Suppl. 3), 6-10. https://doi.org/10.22159/ajpcr.2016.v9s3.14321
- Czyż, A., Zakrzewska-Sito, A., & Kuczyńska, J. (2024). A review of advances in bioanalytical methods for the detection and quantification of olanzapine and its metabolites in complex biological matrices. Pharmaceuticals, 17(3), 403. https://doi.org/10.3390/ph17030403