Introduction: Why E&L Testing Cost Matters More Than Ever in 2026
In 2026, the E&L Testing Cost is a crucial consideration for pharmaceutical companies, biotech startups, and medical device manufacturers navigating evolving global regulations. Extractables and Leachables (E&L) Testing is not just a compliance requirement—it’s a vital step in safeguarding patient safety and product integrity. Understanding how much E&L testing costs in 2026 involves more than quoting a flat fee. It’s about grasping the depth of analytical work, study design, materials used, and regulatory expectations.
At ResolveMass Laboratories Inc., we offer specialized Extractables and Leachables Testing Services supported by industry-leading instrumentation and scientific consultation. Our services are tailored to meet the unique demands of drug-device combination products, packaging materials, and polymeric systems.
See our full E&L testing services here – Choosing the Right E&L Testing Service Provider
What Influences E&L Testing Cost in 2026?
1. Product Complexity & Material Composition
The E&L Testing Cost in 2026 is heavily influenced by the complexity of the product being tested. For example, a single-layer IV bag will be less expensive to evaluate than a combination inhaler with multiple components and interfaces.
The following factors impact your cost:
- Number and diversity of materials (rubbers, plastics, metals)
- Chemical reactivity and potential for extractable compounds
- Novel materials needing customized protocols
Want a custom E&L plan? Learn more here – Customized E&L Testing Solutions for Your Industry
2. Scope of the Analytical Study
An in-depth E&L testing cost also accounts for:
- The number of extraction solvents and conditions
- Study duration (e.g., accelerated vs. real-time)
- Type of simulation (e.g., exhaustive vs. simulated use)
- Testing for volatile, semi-volatile, and non-volatile compounds
Standard studies utilize a combination of GC-MS, LC-MS/MS, ICP-MS, and Headspace Analysis, depending on the regulatory requirements and compound types expected.
3. Regulatory Submissions (FDA, EMA, Health Canada)
The level of E&L testing required differs by regulatory body:
- FDA expects compliance with USP <1663> and <1664>
- EMA requires risk-based analysis and clear justification of extractables
- Health Canada follows ICH Q3E guidelines and demands complete extractable profiles
Compliance with these agencies affects both study design and E&L testing cost, particularly in documentation, validation, and toxicological risk assessments.
Explore our Extractables and Leachables Testing Service Page for our regulatory-compliant testing workflows.
4. The Growing Role of International Harmonization in Cost Planning
Global harmonization initiatives are increasingly shaping E&L study expectations, especially for products intended for multiple markets. As regulatory bodies collaborate through organizations such as ISO and ICH, manufacturers are incentivized to design E&L programs that satisfy several jurisdictions simultaneously. This trend can streamline regulatory pathways and reduce redundant testing, but it also raises the baseline expectations for analytical robustness, documentation standards, and toxicological validation.
The cost implications of harmonization vary depending on the product class. For instance, a device intended only for North American use may not require the same breadth of extractable studies as one destined for the EU, APAC, and LATAM markets collectively. However, companies pursuing global launches can offset higher initial E&L testing costs through faster market access, fewer redesign cycles, and reduced regulatory pushbacks. Strategic planning at the feasibility stage is therefore becoming essential for cost control in 2026 and beyond.
5. Inclusion of Toxicological Risk Assessment
A significant portion of the E&L testing cost in 2026 can come from toxicological evaluation. Once extractables are identified, each compound needs to be:
- Quantified against safety thresholds (e.g., PDE or TTC)
- Evaluated for mutagenicity, carcinogenicity, and cumulative exposure
We offer in-house toxicology expertise, reducing the need for third-party consultants and streamlining your project timeline and cost.
Read how E&L affects patient safety – The Role of E&L Testing in Ensuring Patient Safety
6. Impact of Instrumentation Advancements on Testing Cost
Advances in analytical instrumentation are playing a profound role in shaping modern E&L testing budgets. Technologies such as high-resolution mass spectrometry (HRMS) and time-of-flight analyzers enable faster compound identification, more precise quantitation, and better detection of ultra-trace contaminants. While these tools improve confidence in extractables profiles, they can increase upfront testing rates due to higher operational and maintenance expenses.
Conversely, automation-driven efficiencies are helping laboratories mitigate long-term costs. Automated sample preparation platforms, integrated chromatography systems, and digital spectral libraries reduce labor hours, streamline data interpretation, and minimize repeat testing. Over time, manufacturers benefit from reduced study timelines and fewer regulatory queries, making high-end instrumentation a strategic cost advantage despite initial premium pricing.
E&L Testing Cost Range in 2026
Here’s a general breakdown of current market pricing:
| Study Type | Estimated E&L Testing Cost (USD) |
|---|---|
| Basic Single Material E&L | $5,000 – $15,000 |
| Complex Multi-Material Device | $10,000 – $25,000 |
| Full Extractable + Leachable + Tox Evaluation | $10,000 – $30,000+ |
Every quote from ResolveMass Laboratories is customized based on scope, timeline, and regulatory filing requirements. Begin your project via our Contact Page.
How Study Duration and Phase Impacts Pricing
E&L programs vary substantially depending on the development stage of the product. Early R&D screening studies typically emphasize qualitative detection and exploratory chemistry, allowing teams to identify potential material risks before committing to full regulatory pathways. These early-phase studies are typically more affordable, though they may later expand into full quantitative evaluations once a final design is finalized.
By contrast, validation-phase E&L studies must incorporate simulation of real-world use conditions, leachable migration modeling, and detailed toxicological justifications for regulatory submission. These late-stage studies carry higher complexity, require extensive documentation, and often involve multiple analytical techniques running in parallel. As a result, companies that proactively assess extractables early can significantly reduce late-stage redesigns and associated cost escalations.
How to Get an Accurate E&L Testing Quote
When requesting a quote, provide:
- Material composition and drawings of the product
- Intended market (FDA, EMA, etc.)
- Use-case conditions (e.g., injectable, inhaled, topical)
- Regulatory deadline or launch timeline
Got questions? See our full FAQ here – Top Questions About E&L Testing Answered
Common Cost Mistakes to Avoid in E&L Programs
One of the most frequent errors manufacturers make is delaying E&L consideration until late in the development process. This can result in discovering that certain polymers, adhesives, or coatings are chemically incompatible with the intended drug product, forcing expensive reformulation, redesign, or repackaging efforts. Addressing extractables risks at material selection or prototype phases helps prevent costly surprises during regulatory review.
Another major pitfall is underestimating the documentation burden required by agencies such as the FDA or EMA. Regulators increasingly expect detailed chemical risk assessments, extractable identification rationales, and clear justification for safety thresholds. Inadequate documentation may not only delay approval but also necessitate repeat toxicological analysis, extending both time and budget. Companies that integrate regulatory consulting from the outset tend to experience smoother submissions and reduced overall costs.
Reducing E&L Testing Cost Without Sacrificing Quality
Cost-conscious pharmaceutical and medical device companies can reduce expenses by:
1. Bundling Components into One Study
Combine similar materials/components in a single extraction profile.
2. Starting with Risk-Based Screening
We offer tiered study designs, where initial screens focus only on high-risk components.
3. Choosing an Integrated Testing Lab
By working with ResolveMass—where chemistry, method development, and toxicology are all in-house—you eliminate the overhead of multiple vendors.
Learn more on our full Extractables and Leachables Service Page.
Why Choose ResolveMass for E&L Testing in 2026?
ResolveMass Laboratories Inc. is trusted by innovators across North America for our:
- GLP-compliant, ISO 17025-accredited testing facility
- Proprietary method development workflows
- Deep experience in polymer analysis and degradation profiling
- Speed and transparency in reporting and regulatory alignment
Our team brings decades of combined experience in analytical chemistry, regulatory affairs, and quality assurance—making us a partner, not just a service provider.
See how we solved real client challenges – Case Study: Enhancing Product Safety Through Comprehensive E&L Testing
Read what sets our E&L Testing apart and how we support drug-device innovation from R&D to post-market surveillance.
The Business Case for E&L Testing in Competitive Markets
Beyond regulatory compliance, comprehensive E&L testing has become a differentiator in competitive device and pharmaceutical markets. Healthcare providers, investors, and even procurement agencies increasingly scrutinize the chemical safety profile of products—especially for drug-device combinations and biologics. Manufacturers that demonstrate strong chemical compatibility and leachable control are better positioned to win tenders, partnerships, and commercialization agreements.
Furthermore, robust E&L datasets support long-term value by reducing post-market risk exposure. Product recalls tied to leachables contamination can damage brand reputation and incur substantial legal costs. Integrating E&L testing early not only strengthens patient safety outcomes but also enhances market confidence and provides a strategic buffer against future regulatory tightening. In a landscape where regulatory expectations continue to rise, E&L testing becomes an investment in both safety and commercial longevity.
Conclusion: Invest Wisely in E&L Testing Cost in 2026
If you’re searching how much does Extractables and Leachables (E&L) testing cost in 2026, know this: while the E&L testing cost may seem substantial upfront, it’s an investment in regulatory success, patient safety, and long-term cost avoidance. At ResolveMass Laboratories Inc., we deliver precision, speed, and scientific clarity—making your E&L study not just a checkbox, but a strategic advantage.
Learn how leachables impact medical devices – Leachables in Medical Devices
✅ Let’s talk about your next project:
📩 Contact Us
📞 Schedule a discovery call today: Contact Page
📧 Reach our scientific advisors directly: ResolveMass Contact
🧪 Learn more about Extractables and Leachables Testing
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.
Frequently Asked Questions
The cost of extractable and leachable studies varies widely depending on product complexity, regulatory scope, and toxicological evaluation requirements. Basic single-material screens can start around a few thousand dollars, while comprehensive multi-material or submission-ready studies can reach tens of thousands. These costs account for analytical instrumentation, study design, and documentation needed for regulatory acceptance.
Testing involves exposing the product or packaging materials to controlled conditions and analyzing chemicals that migrate out. Extractables are assessed under aggressive or simulated-use extractions, while leachables are measured in the actual drug product during storage or accelerated aging. Advanced analytical techniques such as GC-MS, LC-MS, ICP-MS, and headspace analysis are typically used.
The extractable test method evaluates which chemical substances can be pulled from materials when subjected to solvents, heat, or mechanical stress. The goal is to create an exaggerated condition that reveals the worst-case chemical profile of a device, closure system, or container. Results inform risk assessments and help predict potential leachables during real-world use.
Leachable testing focuses on compounds that migrate into the drug formulation under normal storage or use conditions. Common analytical methods include mass spectrometry and chromatography platforms that detect volatile, semi-volatile, and non-volatile species. The process frequently aligns with regulatory stability studies and toxicological evaluations.
AET, or Analytical Evaluation Threshold, is the concentration level above which detected compounds must be identified and assessed for safety. It ensures analytical data focuses on substances with potential toxicological relevance rather than inconsequential trace signals. Regulators consider AET a key metric for determining reporting and identification requirements in E&L studies.
REFERENCES
- Rozio, M. G., Angelini, D., & Carrara, S. (2025). Uncertainty factors and relative response factors: Correcting detection and quantitation bias in extractables and leachables studies. Analytical and Bioanalytical Chemistry, 417(19), 4331–4349. https://doi.org/10.1007/s00216-025-05946-5
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use & European Medicines Agency. (2025). ICH Q3E guideline for extractables and leachables (Draft guideline). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q3e-guideline-extractables-leachables_en.pdf
- Balfour, H. (2022, April 29). Advancing extractables and leachables testing. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/
