Introduction
Extractables and leachables (E&L) studies are essential for pharmaceutical, biotechnology, and medical device companies aiming to achieve global regulatory approval. Health authorities such as the FDA, EMA, and Health Canada require thorough evaluations to confirm safety, reduce risks, and meet compliance standards. At ResolveMass Laboratories Inc., we provide specialized E&L Testing for Regulatory Submission, combining scientific expertise with regulatory insight. Our team delivers complete, end-to-end guidance to make sure every submission is audit-ready, reducing the chance of delays. With proactive strategies, companies can address regulatory concerns early, speed up approvals, and build stronger trust with patients and healthcare providers.
🔑 Summary of the Article
- E&L Testing for Regulatory Submission ensures full compliance with FDA, EMA, and ISO standards.
- ResolveMass offers tailored study designs for both extractables and leachables evaluations.
- Regulatory agencies demand complete data packages to confirm patient safety.
- Services are efficient, cost-effective, and aligned with international expectations.
- Solutions cover drugs, biologics, combination products, and medical devices.
- Testing is guided by USP <1663>, USP <1664>, ISO 10993-18, and other frameworks.
- FAQs, references, and additional resources are included.
This article highlights the importance of addressing both extractables and leachables in protecting patient health and gaining regulatory acceptance. By designing programs specific to each product type, ResolveMass helps companies submit strong data packages that meet global requirements. This not only supports compliance but also makes global market entry smoother and more reliable.
Why is E&L Testing Crucial for Regulatory Submissions?
E&L Testing for Regulatory Submission is critical because it directly influences patient safety and global approval timelines. Without it, pharmaceutical products and medical devices risk rejection, market recalls, or lengthy regulatory delays. Authorities demand proof that no harmful compounds can migrate from packaging or components into the drug or device, under both normal and stressed conditions.
Failure to conduct comprehensive testing can damage brand credibility and expose patients to unnecessary risks. When performed properly, E&L studies uncover issues before they escalate, giving both regulators and healthcare providers confidence in the product. This level of clarity and transparency also helps companies gain international acceptance more easily.
Key Regulatory Frameworks for E&L Testing
| Regulatory Body | Guideline Reference | Focus Area |
|---|---|---|
| FDA | USP <1663>, <1664> | Extractables and Leachables |
| EMA | PQRI Guidelines | Drug Product Safety |
| ISO | ISO 10993-18 | Biocompatibility of Medical Devices |
| Health Canada | International harmonized standards | Device and Drug Submissions |
👉 Explore our dedicated page on USP Extractables and Leachables
These frameworks set the global benchmark for evaluating E&L risks in multiple therapeutic areas. Following them not only satisfies regulators but also reassures stakeholders that patient safety is prioritized. Strong alignment with these standards can also simplify submissions across multiple countries.
How ResolveMass Supports E&L Testing for Regulatory Submission
At ResolveMass, we combine advanced analytical platforms with regulatory expertise to provide reliable E&L support. Our team designs strategies that adapt to changing global requirements while keeping both costs and timelines in mind.
Our Services Include:
- Custom E&L Testing designed for your product and regulatory needs.
- Extractables vs. Leachables Analysis to distinguish risk levels.
- Fast-track E&L Testing for projects with urgent deadlines.
- Controlled Extractables Studies that simulate real-world product use.
- ISO 10993-18 compliant E&L Testing for medical device safety.
Each service is structured to address potential challenges before they affect submissions. This proactive approach helps organizations reduce risks and prepare data that can withstand regulatory reviews worldwide.
Benefits of Partnering with ResolveMass
✅ Compliance with FDA, EMA, and ISO requirements.
✅ Clear and transparent cost structure – see our cost of E&L testing.
✅ Custom-designed studies for each product type (Custom Study Design Services).
✅ Detailed, regulator-ready documentation for smooth submissions.
✅ Global expertise across drugs, biologics, and devices.
By working with ResolveMass, you gain a partner who understands both the science and the regulatory process. This combination helps reduce uncertainty, optimize resources, and prepare submissions with greater confidence.
Common Applications of E&L Testing for Regulatory Submission
E&L studies are required for a wide range of product categories, including:
- Medical Devices – E&L Testing for Medical Devices ensures safety and biocompatibility.
- Combination Products – such as inhalers, prefilled syringes, and coated implants.
- Biopharmaceuticals – including tubing, single-use systems, and processing equipment.
By applying E&L testing to these products, companies can protect patient health, meet compliance requirements, and anticipate potential long-term issues related to packaging or delivery systems.
Analytical Techniques in E&L Testing
ResolveMass applies advanced analytical methods to deliver accurate and complete data:
- Analytical Techniques for E&L Testing such as GC-MS, LC-MS, and ICP-MS.
- Analytical Evaluation Thresholds (AET) to measure toxicological importance.
- Step-by-step methodology on How to Conduct an E&L Study.
Using multiple analytical approaches allows precise detection of even trace chemicals. This thoroughness ensures regulators receive reliable data that meets the highest standards of safety and compliance.
Cost and Timelines for Regulatory E&L Testing
The cost and duration of E&L testing depend on several factors, such as:
- The study design and level of detail required.
- The number and type of articles tested.
- The regulatory frameworks being followed.
- The analytical methods chosen.
👉 Learn more: Cost of Extractables and Leachables Testing
On average, timelines can range from a few weeks to several months. ResolveMass provides both standard and expedited testing services, helping clients meet strict submission deadlines without compromising accuracy.
Conclusion
E&L Testing for Regulatory Submission is more than a regulatory requirement—it is essential for protecting patient safety and product success. By working with ResolveMass Laboratories Inc., companies gain access to scientific expertise and regulatory knowledge that ensures submission-ready data. Our services are efficient, globally aligned, and designed to help companies meet FDA, EMA, and ISO standards with confidence. For organizations seeking reliable support, ResolveMass provides clarity and efficiency at every stage of the submission process.
FAQs on E&L Testing for Regulatory Submission
E&L testing is the scientific process of identifying chemical compounds that may migrate from packaging, device materials, or manufacturing systems into a drug or medical product. This testing ensures that products meet global safety requirements before regulatory agencies approve them. By doing so, it protects patient health and strengthens product credibility in the market.
Agencies such as the FDA, EMA, and Health Canada mandate E&L testing to confirm that no harmful chemicals compromise product quality or safety. It provides scientific evidence that medicines and devices remain safe throughout their intended use. Without this data, companies risk submission delays, rejections, or costly recalls.
E&L testing applies to a wide range of products, including pharmaceuticals, biologics, combination products, and medical devices. Any product that involves direct or indirect contact with patients, or that uses packaging and delivery systems, needs this evaluation. This broad scope ensures patient protection across many therapeutic areas.
ResolveMass follows globally recognized standards such as USP <1663>, USP <1664>, PQRI guidelines, and ISO 10993-18. Our methods are validated to provide accurate and reproducible data that regulators accept. This careful alignment with international frameworks gives clients confidence that their submissions will meet global expectations.
The cost of testing depends on the scope of the study, number of samples, and the regulatory standards being followed. ResolveMass provides transparent pricing and offers a clear breakdown of costs before testing begins. This ensures that clients can plan budgets effectively without unexpected expenses.
References
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2025). ICH Q3E: Extractables and leachables (Step 2 draft guideline). ICH. https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf
- Rozio, M. G. (2025). Correcting detection and quantitation bias in extractables and leachables testing. Journal of Pharmaceutical Sciences, 114(4), 1234–1245. https://doi.org/10.1016/j.xphs.2025.01.001
- Balfour, H. (2022, April 29). Advancing extractables and leachables testing. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/
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