Introduction: Choosing the Right E&L Testing CRO in 2025
As regulatory expectations evolve and the demand for high-precision analytical testing grows, selecting the right E&L Testing CRO (Contract Research Organization) has never been more crucial. Whether you’re developing a novel drug-device combination product or qualifying polymeric components for pharmaceutical packaging, the quality and reliability of your E&L Testing CRO directly impact your product’s regulatory success.
At ResolveMass Laboratories Inc., we serve as a full-spectrum E&L Testing CRO, helping companies across North America streamline their extractables and leachables studies with precision, speed, and scientific rigor. With 2025 well underway, here are the 7 must-have capabilities you should demand from your E&L Testing CRO.
1. Regulatory-Driven Study Design Expertise
Why It Matters:
Your E&L Testing CRO must understand the nuances of regulatory guidelines, such as:
- USP <1663> and <1664> for pharmaceutical packaging
- ISO 10993-18 for medical devices
- FDA, EMA, and Health Canada requirements for combination products
ResolveMass Laboratories brings deep regulatory insight into every study. Our Extractables and Leachables Testing services are designed to meet global standards with custom protocols tailored to your filing region.
🔗 Further Reading: The Importance of E&L Testing – Regulatory Perspectives
Want to learn more about regulatory agencies point of view ? Read this expert article to know region-specific adherence guidance from FDA, EMA, USP, and ISO standards.
2. Comprehensive Analytical Instrumentation
Key Tools Your E&L Testing CRO Should Offer:
- GC-MS / GCxGC-MS for volatile and semi-volatile organic compounds
- LC-MS/MS and UPLC for non-volatiles and degradation products
- ICP-MS for elemental impurities and trace metals
- Headspace GC for residual solvents and extractables
Our lab at ResolveMass is equipped with advanced platforms to support full-scope Extractables and Leachables Testing, enabling high sensitivity and specificity across material classes.
Each of these tools showcases different strength. This article will provide you insights about techniques used in E&L testing.
👉 Read the full article3. Material Science and Polymer Characterization
A top-tier E&L Testing CRO must have a deep understanding of polymers and manufacturing processes. Material selection, processing conditions, and additive profiles all influence the extractables profile.
ResolveMass combines chemical analytics with polymer expertise, providing insights that go beyond data—helping you interpret how extractables relate to your product’s materials and long-term stability.
Explore our integrated Extractables and Leachables Testing Services for drug-contact materials and packaging systems.
4. Toxicological Risk Assessment Capabilities
Identifying extractables is only half the battle—your E&L Testing CRO must also assess their toxicological relevance.
ResolveMass provides:
- Compound-specific toxicology evaluations
- TTC (Threshold of Toxicological Concern)-based assessments
- Support for Permitted Daily Exposure (PDE) limits
- Risk-based justification for unqualified leachables
This reduces your dependency on third-party consultants, saves time, and ensures a seamless regulatory narrative from lab to submission.
5. GLP Compliance and ISO Accreditation
Compliance is non-negotiable when selecting an E&L Testing CRO. A qualified lab must demonstrate adherence to:
- GLP (Good Laboratory Practices)
- ISO/IEC 17025 accreditation for analytical testing
- Data integrity protocols aligned with ALCOA+ standards
ResolveMass Laboratories is proud to operate under full compliance, with validated methods, controlled environments, and audit-ready documentation for all Extractables and Leachables Testing projects.
Whether you’re designing a container system, handling with novel substances, or targeting leachables, custom method development is critical. This blog will explain the influence of CRO in your projects.
👉 Explore the full guide6. Transparent Project Management and Timelines
Your E&L Testing CRO should never keep you guessing. You need:
- Defined timelines and milestone tracking
- Real-time project updates
- Clear points of contact and scientific advisors
- Flexible scope adjustments based on regulatory feedback
At ResolveMass, we assign a dedicated project manager and scientific lead to each client, ensuring your project stays on track and on spec—especially when your regulatory submission timeline is critical.
💵 Understanding the Cost of E&L Testing: What to Expect
👉 Explore cost breakdowns and savings insights
7. Integration with Custom Method Development & R&D
More than a testing provider, your E&L Testing CRO should also act as your analytical R&D partner. Whether you need a custom method to detect unique leachables or require support in early product development stages, a collaborative CRO can help optimize your formulation and packaging strategy.
ResolveMass offers custom method development, early-phase screening, and predictive modeling through our Extractables and Leachables Testing Program. Our expertise accelerates the development cycle and prevents costly delays.
Want to see how E&L testing can directly influence risk mitigation and regulatory strategy in real-world applications? This case study explores how ResolveMass helped identify and control leachables in a complex biologic vial system.
👉 Read the full case studyBonus: Why ResolveMass is the Preferred E&L Testing CRO in 2025
ResolveMass Laboratories Inc. stands out as a leading E&L Testing CRO for:
- Deep regulatory expertise across North American, EU, and APAC markets
- Proprietary workflows built for biologics, injectables, inhalers, and more
- Rapid turnaround and clear, defendable reports
- Personalized scientific consultation and project customization
- Full alignment with 2025’s evolving regulatory landscape
We are proud to serve clients ranging from early-stage startups to global pharmaceutical leaders—all seeking robust, reliable, and regulator-ready data.
Conclusion: Choose the Right E&L Testing CRO to Reduce Risk and Accelerate Success
In 2025, the stakes are higher than ever. Choosing an E&L Testing CRO with the right mix of capabilities—regulatory fluency, advanced analytics, risk assessment, and project transparency—can mean the difference between a smooth submission and costly delays.
ResolveMass Laboratories Inc. offers all seven must-have capabilities and more. We don’t just generate data—we generate confidence.
📩 Ready to start your E&L testing project?
👉 Contact ResolveMass Laboratories Now
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🧪 Learn more about our Extractables and Leachables Testing Services
ResolveMass Laboratories Inc.: Comprehensive Scientific Expertise You Can Rely On
ResolveMass Laboratories Inc. is a trusted Canadian contract research organization offering a wide spectrum of specialized services spanning polymer synthesis, advanced analytical testing, and custom organic synthesis. With over a decade of experience supporting pharmaceutical, biotech, and industrial clients, we bring scientific precision and regulatory insight to every project. Our core capabilities include Polymer Synthesis and Characterization, Peptide Characterization, Organic Synthesis, Nitrosamine Testing and Analysis, PFAS Testing, and Extractable & Leachable Studies, as well as a broad suite of analytical techniques such as HPLC, GC-MS, MALDI-TOF, NMR, and FTIR.
Our multidisciplinary team includes chemists, analytical scientists, and regulatory experts with advanced academic and industry backgrounds. We excel at developing customized, high-quality solutions—whether you need innovative polymer designs, impurity profiling, or confirmatory testing that meets global regulatory standards.
Clients across North America choose ResolveMass Laboratories for our deep technical knowledge, commitment to quality, and ability to deliver reproducible, reliable data that drives confident decision-making. When precision, innovation, and trust matter—ResolveMass is your partner of choice.
We have PhD level scientist who share this knowledge to you so that you can excel in your impurity identification project. This guide will help you understand all the relevant technical aspects, still if you need more help to understand more in your impurity identification, feel free to book a free consultation with our scientist for your project.
REFERENCES
- Thomas F. Understanding Evolving E&L Regulations. In the Lab eNewsletter. 2020 Jan 8;15(1).
- Vas G, Fleck L, Comstock K, Cole J. Extractable and leachable testing for pharmaceutical packaging, finished pharmaceutical products, and medical devices: an analytical perspective.
- Ramamoorthy S, Chong NS, Hotha KK. Strengthening Extractable & Leachable Study Submissions: Best Practices to Avoid Regulatory Deficiencies. American Journal of Analytical Chemistry. 2024 Dec 5;15(12):368-94.
