Summary
- ResolveMass Laboratories Inc. provides Analytical Method Development Services with fast turnaround and competitive quotes.
- Specialized in complex APIs, bioanalytical quantification, impurity profiling, nitrosamine analysis, and residual solvent testing.
- ISO-compliant methods tailored to your regulatory requirements.
- Decades of combined expertise in pharmaceutical, biotech, and chemical industries.
- Streamlined ordering process for analytical method development — from consultation to validated method delivery.
- Services ensure accuracy, reproducibility, and compliance with FDA, ICH, and Health Canada guidelines.
- Contact us for custom solutions and rapid project initiation.
Introduction
Choosing ResolveMass Laboratories means choosing a partner who values precision, compliance, and speed. Our Analytical Method Development Services provide fully validated and regulatory-approved methods that ensure accurate and reproducible results. This helps you achieve product safety, maintain compliance, and reach the market faster.
We specialize in solving complex analytical problems, from API method development to advanced impurity profiling. Our approach is built to handle the unique chemical properties of your product while meeting — and often exceeding — global standards. This way, you avoid costly delays and compliance issues.
Learn more:
Method Development for Complex APIs
Bioanalytical Quantification of drug molecules
Impurity profiling using LCMS
Why Choose ResolveMass Laboratories
Proven Expertise Across Multiple Industries
Our scientists bring decades of experience in:
- Pharmaceuticals
- Biotechnology
- Nutraceuticals
- Specialty chemicals
We have successfully led projects through FDA and EMA audits, and our team members have contributed to recognized publications in analytical chemistry. With a mix of proven techniques and innovative solutions, we deliver results even for highly complex analytical challenges.
Commitment to International Standards
Every method is developed in strict alignment with:
- ICH Q2(R2) guidelines
- USP/EP/JP pharmacopeial standards
- FDA and Health Canada expectations
We perform detailed internal quality checks at every stage, ensuring each parameter meets or exceeds the required benchmarks for accuracy, precision, and robustness.
Scope of Our Analytical Method Development Services
| Service Type | Key Features | Learn More |
|---|---|---|
| Method Development for Complex APIs | Solubility challenges, stability testing, degradation studies | Read More |
| Bioanalytical Quantification | LC-MS/MS, PK/PD studies, trace-level quantitation | View Service |
| Impurity Profiling | Identification, quantification, toxicological assessment | Explore |
| Nitrosamine Analysis | Risk assessment, NDMA testing | More Info |
| Residual Solvent Testing | Headspace GC, Class 1-3 solvents per ICH Q3C | Service Page |
We guide projects from feasibility studies to full validation, using advanced instruments and proven methods to deliver high sensitivity, specificity, and reproducibility. This ensures your results are ready for both scientific review and regulatory approval.
Fast Turnaround & Clear Pricing
We know time is critical. Our process is streamlined to deliver results quickly without sacrificing quality:
- Submit Your Project Details – Share your API, sample matrix, and testing objectives.
- Receive a Custom Quote – Transparent pricing based on project complexity.
- Method Development – Includes research, feasibility tests, and optimization.
- Validation & Reporting – Complete documentation for regulatory submission.
With our fast-track service, urgent projects can be completed in as little as five business days, helping you stay on schedule.
Ready to begin? Visit our Method Development Service page for fast quotes.
Key Advantages of Our Approach
- Custom methods — never one-size-fits-all templates
- ISO and GLP compliant for consistent quality
- Complete audit-ready documentation
- Integration of stability and impurity studies for full product insight
- Access to advanced tools like LC-MS/MS, GC-MS, ICP-MS, and UHPLC
By blending regulatory compliance with practical problem-solving, we ensure every method is reliable and ready for long-term use in your workflow.
Client Success Story
A biotechnology company faced challenges with a low-solubility API that degraded quickly. Our team:
- Designed a stability-indicating UHPLC method within 10 business days
- Validated it according to ICH Q2(R2) standards
- Delivered results that allowed the client to submit data two months ahead of schedule
This saved the company time, reduced costs, and avoided potential delays in their product launch.
Conclusion
Partnering with ResolveMass Laboratories for Analytical Method Development Services means gaining a reliable, experienced, and responsive analytical partner. From complex API testing to impurity profiling and residual solvent analysis, we deliver accurate, compliant, and fast results that help you meet your project goals with confidence.
Get started today:
FAQs — Analytical Method Development Services
Our methods are developed in line with international standards such as ISO 10993-18, USP, ICH, and FDA guidelines. We tailor the process to match your product’s target market, ensuring that the final method is accepted by the relevant authorities. This helps avoid delays during product approval stages.
Our lab is equipped with advanced tools including LC-MS, GC-MS, ICP-MS, and HPLC systems. The choice of instrument depends on your product’s specific testing needs and the required detection limits. We always select the technology that will give the most reliable and defensible results.
Absolutely — we specialize in Analytical Method Development Services for medical devices, especially extractables and leachables (E&L) studies. Our work supports ISO 10993-18 compliance and has successfully passed both FDA and EU MDR reviews, ensuring safe and compliant products for patient use.
Pricing is based on factors such as project scope, complexity, instrumentation, and validation requirements. We provide instant, transparent quotes so you can plan your budget effectively. There are no hidden fees, and you’ll always know exactly what’s included.
The timeline depends on the complexity of your project and the regulations involved. Most Analytical Method Development Services we provide are completed within 2–6 weeks, including method design, optimization, and validation. We prioritize efficiency without compromising accuracy or compliance.
