Analytical Method Development and Validation Service

🧬 INTRODUCTION

At ResolveMass Laboratories Inc., our Analytical Method Development and Validation Service is designed to deliver accurate, reproducible, and regulatory-compliant analytical solutions for complex pharmaceutical, biopharmaceutical, and life science applications. With hands-on scientific experience, advanced instrumentation, and a deep understanding of global regulatory expectations, we help organizations generate reliable analytical data generation using proven techniques such as HPLC analysis and mass spectrometry-based methodologies to strengthen product development, regulatory submissions, and long-term quality assurance.

✅ KEY VALUE PROPOSITION

Scientifically sound and lifecycle-based analytical methods
Full compliance with ICH, USP, FDA, and EMA guidelines
Methods tailored to your molecule, matrix, and regulatory pathway
Robust documentation suitable for audits and submissions
Experienced analytical scientists with real-world laboratory expertise

🔬 ANALYTICAL METHOD DEVELOPMENT SERVICES

Analytical Method Development Expertise

ResolveMass Laboratories Inc. specializes in the development of fit-for-purpose analytical methods that ensure precision, specificity, and robustness throughout the product lifecycle. Our scientists apply scientific risk assessment and experimental design while leveraging advanced platforms such as high-resolution mass spectrometry (HRMS) analysis to address complex analytical challenges under real manufacturing and stability conditions.

HPLC, UHPLC, and LC-MS method development
Assay and impurity profiling methods
Stability-indicating method development
Dissolution and release testing methods
Residual solvent and elemental impurity analysis
Forced degradation and stress testing studies

🧾 ANALYTICAL METHOD VALIDATION SERVICES

Regulatory-Compliant Method Validation

Our Analytical Method Development and Validation Service includes full validation studies conducted in accordance with ICH Q2(R1/R2), USP <1225>, and regulatory authority expectations. For high-risk impurities and evolving regulatory concerns, our validation strategies integrate specialized testing such as nitrosamine analysis to ensure patient safety and regulatory readiness. Each validation is scientifically justified, statistically evaluated, and fully documented to withstand regulatory review and inspections.

Accuracy, precision, and intermediate precision
Specificity and selectivity
Linearity and range
Detection and quantitation limits (LOD/LOQ)
Robustness and system suitability
Method transfer and verification support

🌍 REGULATORY & QUALITY COMMITMENT

Built for Global Regulatory Acceptance

ResolveMass Laboratories Inc. operates with a quality-driven mindset, ensuring every analytical method aligns with current regulatory guidance and data integrity principles. Our validation protocols, reports, and raw data packages—supported by advanced analytical technologies including LC-MS–based impurity profiling—are prepared to support IND, NDA, ANDA, and MA submissions, as well as internal audits and regulatory inspections.

🏭 INDUSTRIES WE SERVE

Industries & Applications

Pharmaceutical and generic drug manufacturers
Biopharmaceutical and biologics developers
Contract development and manufacturing organizations (CDMOs)
Specialty chemicals and intermediates
Research and innovation-focused life science companies

⭐ Why RESOLVEMASS LABORATORIES INC. A Trusted Partner in Analytical Science

ResolveMass Laboratories Inc. is trusted by clients who value scientific rigor, transparency, and dependable results. Our analytical scientists bring extensive hands-on laboratory experience across platforms such as HPLC analysis, GC-MS, and HRMS, applying a problem-solving mindset to every project. We don’t just validate methods—we build analytical strategies that support long-term product success and regulatory confidence.

Partner with Experts in Analytical Method Development

When accuracy, compliance, and scientific credibility matter, ResolveMass Laboratories Inc. delivers proven solutions through its Analytical Method Development and Validation Service. Our expert-driven approach ensures your analytical methods are reliable, defensible, and ready for regulatory scrutiny—today and throughout the product lifecycle.

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❓Frequently Asked Questions

What are the basics of analytical method validation?

Analytical method validation confirms that a testing procedure consistently produces accurate and reliable results for its intended purpose. It involves evaluating parameters such as accuracy, precision, specificity, linearity, and robustness. The goal is to ensure the method performs effectively under defined laboratory conditions and meets regulatory expectations.

What is the difference between analytical method development and validation?

Analytical method development focuses on designing and optimizing a testing procedure to measure a specific analyte accurately. Validation, on the other hand, proves that the developed method performs consistently and reliably according to predefined criteria. Development builds the method, while validation confirms its suitability for routine use.

What is Phase 3 method validation?

Phase 3 method validation is conducted during late-stage clinical development or before commercial manufacturing. It ensures the analytical method is fully validated, highly robust, and suitable for long-term routine testing. At this stage, methods must meet strict regulatory requirements for product approval and commercialization.

Why do we validate analytical methods?

Analytical methods are validated to ensure test results are accurate, consistent, and scientifically defensible. Validation reduces the risk of errors, supports regulatory compliance, and builds confidence in data used for quality control and decision-making. It also ensures product safety and efficacy throughout its lifecycle.

What is LOD and LOQ in method validation?

LOD (Limit of Detection) is the lowest amount of analyte that can be detected but not necessarily quantified accurately. LOQ (Limit of Quantitation) is the lowest level that can be measured with acceptable precision and accuracy. Both parameters define the sensitivity of an analytical method.

What are the challenges in analytical method development?

Challenges in analytical method development include achieving adequate specificity, sensitivity, and robustness for complex samples. Variability in raw materials, matrix interferences, and evolving regulatory expectations can complicate method optimization. Balancing performance, cost, and scalability is also a key challenge.

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(3)%209%20ravisankar%202%201183-1195.pdf
Rina, R., Baile, M., & Jain, A. (2021). A review: Analytical method development and validation. Systematic Reviews in Pharmacy, 12(8), 450–454. Retrieved from https://www.sysrevpharm.org/articles/a-review-analytical-method-development-and-validation.pdf

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Need Reliable Analytical Methods That Meet Regulatory Expectations?

ResolveMass Laboratories Inc. provides tailored analytical method development and validation solutions designed to support your product’s success from early development through commercialization.