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Custom Analytical Method Development for Drug Discovery
Accelerating R&D success through validated, compliant, and tailored analytical solutions built for modern biopharmaceutical innovation.
In today’s competitive pharmaceutical landscape, Custom Analytical Method Development for Drug Discovery has become a central driver in accelerating successful clinical candidates. At ResolveMass Laboratories Inc., we support biotech startups, pharmaceutical companies, and research institutions with tailored analytical approaches designed to enhance decision-making, reduce development risks, and streamline regulatory approval pathways.
Advance your research with precision. Discover our full range of professional Bioanalytical Services today.
Challenges in Drug Discovery Analytical Testing
Developing new molecular entities requires analytical precision at every stage. Many organizations struggle with:
- Limited analytical characterization capacity
- Regulatory expectations for validated method performance
- Insufficient reproducibility across test sites
- Complex molecule stability and impurity profiling
- Delayed IND/IMPD submissions due to missing analytical data
Our laboratory services are designed to eliminate these friction points and support program success from early R&D to late-stage development.
Our Analytical Method Development Capabilities
ResolveMass Laboratories Inc. specializes in scalable analytical solutions for small molecules, biologics, peptides, and novel modalities. Our team integrates deep scientific knowledge with state-of-the-art instrumentation to deliver high-confidence results.
Our core method development capabilities include:
- Quantitative & qualitative assay development
- Impurity and degradation profiling
- Forced degradation and stability studies
- Pharmacokinetic (PK) & bioanalytical method development
- Release and characterization testing
- Method transfer & site bridging support
- Phase-appropriate method validation
Ensure the purity and safety of your compounds. Explore our specialized Impurity Profiling using LCMS to secure your data integrity.
Our Technical Instrumentation Platform
We continuously invest in advanced analytical instrumentation to handle increasingly complex therapeutics, including:
- LC-MS/MS & HR-MS
- UHPLC/HPLC systems
- ICP-MS & GC-MS
- CE-SDS & iCIEF
- UV-Vis & Fluorescence
- Automated sample preparation
This infrastructure enables broad molecular characterization with sensitivity, precision, and reproducibility that supports regulatory expectations.
Unlock deeper molecular insights, Learn how our high-resolution HRMS Analysis can elevate your drug development program.
Method Development Workflow
Our method development follows an iterative and phase-appropriate approach:
- Analytical requirements assessment
- Molecule-specific feasibility analysis
- Preliminary method draft & optimization
- System suitability assessment
- Phase-appropriate validation
- Technology transfer (if required)
- Regulatory documentation support
Bridge the gap between synthesis and analysis – Learn more about our Custom Synthesis for Drug Discovery solutions.
Regulatory & Quality Alignment
We align our analytical practices with global regulatory frameworks to ensure compliance and approval readiness, including:
- ICH Q2(R2) validation guidelines
- ICH M10 bioanalytical method validation
- FDA & EMA expectations
- GLP & GMP quality systems
Mitigate regulatory risks early – Access our expert Nitrosamine Testing and Analysis services to ensure compliant submissions.
Example Program Success (Case Snapshot)
A venture-backed biotech engaged ResolveMass to develop bioanalytical methods for a peptide-based therapeutic entering Phase I. Through tailored LC-MS/MS assay development and rapid validation, the team met IND submission timelines and reduced external CRO transfer delays. Program advanced to FIH studies with reproducible site performance.
Why Select ResolveMass Laboratories Inc.
Our clients choose us for:
- Deep scientific and regulatory experience
- Modern analytical infrastructure
- Collaborative project communication
- Startup-friendly project timelines
- Audit-ready documentation practices
Additional trust indicators include:
- Experienced PhD-level analytical staff
- GMP/GLP-compliant quality systems
- Transparent data traceability
- Secure sample management processes
Industries & Modalities We Support
- Small molecule therapeutics
- Peptide & protein therapies
- RNA-based modalities
- Cell & gene therapy
- Biomarkers & PK studies
- Pre-clinical to clinical development
Conclusion – Accelerate Your Discovery Pipeline
Whether you are advancing early R&D or preparing a clinical submission, ResolveMass Laboratories Inc. offers reliable Custom Analytical Method Development for Drug Discovery designed to shorten timelines and improve regulatory confidence. Connect with our team to discuss your program needs.
Frequently Asked Questions
Custom analytical method development involves designing and optimizing laboratory procedures to accurately measure and characterize a drug compound. These methods help scientists understand purity, potency, stability, and molecular behavior throughout R&D and clinical phases.
In early R&D, analytical methods guide decision-making by revealing key data such as degradation pathways, impurity profiles, and pharmacokinetic behavior. Reliable methods reduce scientific uncertainty and help determine whether a candidate is worth moving into clinical development.
Techniques vary by molecule type but typically include LC-MS/MS, HPLC/UHPLC, GC-MS, CE, and UV-Vis spectroscopy. These tools enable sensitive detection and quantification of active compounds, impurities, metabolites, and degradation products.
Small molecules, peptides, biologics, RNA modalities, and cell & gene therapy products often need tailored analytical approaches. Each class presents unique analytical challenges due to differences in structure, stability, and detection requirements.
Reference
- Ravisankar, P., Gowthami, S., & Devlala Rao, G. (2014). A review on analytical method development. Indian Journal of Research in Pharmacy and Biotechnology, 2(3), 1183–1195. Retrieved from https://www.ijrpb.com/issues/Volume%202_Issue%203/ijrpb%202%283%29%209%20ravisankar%202%201183-1195.pdf
- Amrutkar, A., Aher, S., & Bachhav, R. (2023). A comprehensive review on analytical method development and validation. International Journal of Pharmaceutical Sciences, 1(3), 112–124. https://doi.org/10.5281/zenodo.6260581
- Raysing, S., Patil, M., & Patil, A. (2021). Analytical method development and validation: A concise review. International Journal of Pharmacy and Biological Sciences (IJPBS), 11(1), 9–16. https://www.ijpbs.com/ijpbsadmin/upload/ijpbs_602cb529dbe44.pdf
- Sudha, T., Krishna Kanth, V., Nukala Poorana Chandra Sainath, S., Mishal, Saloman Raja, T., & Ganesan, V. (2012). Method development and validation – A review. Journal of Advanced Pharmacy Education & Research, 2(3), 146–176. Retrieved from https://japer.in/storage/models/article/fJSyEx3VH6Dmeu2nFuT9xzSZ3pRFPtd0wLKga162fUvldW0m1cHhAuc48NAb/method-development-and-validation-a-review.pdf