In the pharmaceutical, biotech, and medical device industries, safety and compliance are not optional—they’re essential. That’s where E&L Testing Services come in. These tests help detect harmful chemicals that could leak from packaging into the drug product. Selecting the right E&L testing partner can make a big difference in the success of your product, ensuring both regulatory approval and patient safety.
ResolveMass Laboratories is one of the leading providers of E&L Testing Services in North America. With strong scientific knowledge and deep regulatory understanding, they deliver results that meet global standards.
What Are E&L Testing Services?
E&L Testing Services help detect and measure chemicals that might come from packaging, containers, or drug delivery devices and end up in the drug itself. Extractables are substances that can be pulled out of materials when exposed to strong solvents or high temperatures in lab tests designed to simulate worst-case situations. On the other hand, leachables are the actual chemicals that migrate into the product during normal storage or use. These substances can pose health risks to patients and are carefully analyzed using advanced and highly sensitive testing methods.
These tests are important to make sure that the materials used in your product’s packaging or delivery system do not release harmful chemicals into the drug. Without proper E&L testing, there is a risk of chemical contamination, which could lead to delays in approval—or even rejection—by regulatory authorities.
👉 Learn more: Extractables and Leachables Testing Overview
Why Choose ResolveMass for E&L Testing Services
When it comes to E&L Testing Services, ResolveMass stands out for their experience, technology, and regulatory support. Their team works across many product types, including:
- Injectable drugs
- Inhalation and nasal products
- Ophthalmic and parenteral formulations
- Biologics and cell or gene therapies
👉 Related: E&L Testing for Inhalation and Nasal Drug Products
Advanced Equipment for E&L Testing Services
ResolveMass applies advanced tools such as GC-MS, LC-MS/MS, ICP-MS, FTIR, and headspace analysis to carry out accurate and dependable chemical testing as part of its E&L Testing Services. These modern technologies can detect even the smallest traces of substances that might affect product safety. Each method is carefully validated to ensure clear identification and measurement, giving clients the strong data needed for regulatory submissions and toxicology evaluations.
Their methods are fully aligned with global regulatory standards. This means you can trust their data during submissions to agencies like the FDA, EMA, and Health Canada.
E&L Testing Services Backed by Regulatory Expertise
ResolveMass offers more than just testing—they also support you in creating complete, submission-ready documents for global regulatory agencies. Their experts work closely with your quality and regulatory teams to meet important standards like ICH Q3E, USP <1663>/<1664>, and ISO 10993. This team-based approach ensures that your data is thorough, scientifically sound, and fully aligned with the latest regulatory guidelines.
This partnership approach not only saves time but also reduces the chances of surprises during review.
What to Look for in an E&L Testing Services Provider
Strong Science and Lab Infrastructure
A reliable E&L testing partner should offer proven testing methods and up-to-date laboratory equipment. It’s also important that they provide services like toxicological risk assessments and material compatibility studies to help ensure your product is both safe and compliant with regulations. The ability to customize testing protocols for specific formulations or complex drug delivery systems can play a major role in the success of your E&L Testing Services program.
ResolveMass offers all of this, helping you manage risk and stay ahead of regulatory requirements.
👉 More details here: Extractable and Leachable (E&L) Services
Fast Turnaround with Flexible Services
ResolveMass provides complete E&L Testing Services reports within 4 to 8 weeks, offering a fast turnaround while maintaining high quality. Whether you’re in early development or close to product launch, their team can adjust the testing plan to match your timeline and project needs. This flexibility helps speed up regulatory submissions and keeps your development process moving without delays.
In today’s fast-paced development cycles, speed and flexibility are critical.
Clear and Honest Pricing
ResolveMass follows a clear and honest pricing approach, with no hidden fees or unexpected costs. Their flexible pricing structure is designed to help you manage your budget effectively, regardless of how complex your project is. Each quote is tailored to your specific needs, so you only pay for the exact E&L Testing Services required—no unnecessary extras.
👉 Get pricing: E&L Testing Cost Guide
👉 Compare: Cost of Extractables and Leachables Testing
Proven Project Experience
With more than 800 completed E&L Testing Services projects, ResolveMass offers extensive experience across a wide range of products. Their team has handled everything from injectable drugs and inhalation systems to cutting-edge biologics and ophthalmic formulations. This strong background in real-world testing allows them to deliver customized solutions based on proven methods and reliable data.
This experience helps them predict challenges and offer better solutions right from the start.
Strong Client Collaboration
Each E&L Testing Services project at ResolveMass comes with a dedicated project manager who stays actively involved from start to finish. You’ll receive regular updates, quick responses to questions, and support that aligns with your project timelines. ResolveMass focuses on building clear, transparent partnerships, so your team stays informed and confident throughout every phase of the testing process.
This kind of hands-on support makes the testing process smoother and more reliable.
Industries That Use E&L Testing Services from ResolveMass
ResolveMass works with a wide variety of clients, including:
- Pharmaceutical manufacturers
- Biotech companies
- Medical device makers
- Packaging suppliers
- CDMOs and CROs
Their experience with different industries helps them understand and solve unique testing challenges.
Explore our Extractables & Leachables Services for a deeper understanding of how we support cross-industry requirements.
How ResolveMass Shows Expertise and Trust
ResolveMass follows the EEAT principles—Experience, Expertise, Authoritativeness, and Trustworthiness—through:
- A team of PhD chemists, toxicologists, and regulatory experts
- Regular publishing in scientific journals and conferences
- Operating an ISO 17025-accredited lab
- Maintaining high client retention due to proven results
Their reputation for excellence makes them a trusted name in E&L Testing Services.
The ResolveMass Advantage in E&L Testing
When you choose ResolveMass, you’re not just buying a service—you’re getting a long-term partner. They provide:
- Full compliance with FDA, EMA, and ICH guidelines
- Expert toxicology risk evaluations
- Complete support for QA, R&D, and regulatory submissions
- Ready-to-submit reports and helpful guidance
Their well-rounded approach helps keep your product safe and on track for market success.
👉 Let’s talk: Contact ResolveMass
Conclusion: Why ResolveMass Is the Best Partner for E&L Testing Services
Choosing the right partner for E&L Testing Services has a direct impact on your entire development process, from ensuring product safety and meeting regulations to gaining market approval. ResolveMass Laboratories provides a full-service solution powered by advanced science, modern technology, and a team-focused approach. Their goal is to make complex testing easier to navigate while helping your product move smoothly through every regulatory stage.
With E&L Testing Services from ResolveMass, you can move forward with confidence, knowing your product is in expert hands.
Let ResolveMass be your first—and final—choice in E&L testing services.
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FAQs
Any pharmaceutical or medical product that comes into contact with packaging or device components—such as syringes, vials, inhalers, or IV bags—requires E&L Testing Services. These tests confirm that the materials used won’t introduce harmful chemicals into the product over time.
At ResolveMass, E&L testing typically takes between 4 to 8 weeks, depending on the project’s complexity. Timelines can be adjusted based on the development phase, ensuring your product stays on track without compromising quality or compliance.
E&L Testing Services must comply with global standards like ICH Q3E, USP <1663>/<1664>, ISO 10993, and guidelines from regulatory bodies such as the FDA, EMA, and Health Canada. Meeting these standards ensures the safety and acceptance of your product worldwide.
Toxicologists evaluate leachables by comparing their levels to safety thresholds such as the Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC). This helps determine if the detected compounds pose any risk to patients during normal product use.
ResolveMass stands out for its experience, speed, and collaborative approach. With over 800 E&L Testing Services projects completed, the team offers deep regulatory insight, advanced tools, and tailored support—ensuring high-quality results from start to finish.
The cost of E&L Testing Services depends on the scope of the project, sample types, and regulatory requirements. ResolveMass offers transparent, customized pricing, so you only pay for the services you need, helping you stay within budget without surprises.
An E&L simulation study replicates real-world conditions to see how chemicals might leach from materials into the drug product over time. This helps predict potential safety risks and provides valuable data for regulatory submissions.
