Why Custom E&L Testing Is Essential in Regulated Industries
In today’s tightly controlled healthcare and pharmaceutical sectors, Custom E&L Testing is no longer a choice — it’s a must for regulatory compliance and product safety. Whether you’re developing a new drug, medical device, or advanced packaging system, tailored extractables and leachables testing helps you stay compliant with global standards while protecting patient health.
At ResolveMass Laboratories, we create custom strategies based on your materials, drug forms, delivery methods, and target markets. Our testing programs follow major guidelines, including FDA, EMA, USP <1663>/<1664>, and ICH. We don’t just test — we work closely with your team to ensure every study meets regulatory expectations.
If you’re in early development or preparing for global submission, we’re here to reduce risk and help you move forward with confidence. Explore our full spectrum of E&L Testing Services and discover how ResolveMass ensures safety, performance, and global regulatory alignment through our custom testing approaches.
What Is Custom E&L Testing?
Custom E&L Testing means designing a testing plan that fits your specific product and how it interacts with packaging, devices, or drug delivery systems. It goes beyond generic solutions and focuses on real-world risks tied to your materials and use case. This approach ensures that potential leachables are identified before they become a regulatory or safety concern. By targeting known risk areas, it helps you save time, reduce costs, and improve product confidence.
We provide testing for:
- Drug containers and closures
- Combination products like auto-injectors
- Inhalation and nasal delivery systems
- Biologic and sterile injectable products
With a personalized approach, we give you accurate data that helps ensure safety, quality, and compliance throughout your product’s lifecycle.
Discover our capabilities for extractable and leachable EL services today.
Why Custom E&L Testing Matters for Different Sectors
1. Pharmaceuticals and Biologics
Sensitive drugs like injectables, biologics, and inhaled products are at risk of contamination from packaging materials. Even tiny amounts of unwanted chemicals can affect the drug or harm the patient.
That’s why our Custom E&L Testing focuses on identifying possible leachables early in the process. We design studies that meet both scientific and regulatory needs, helping you avoid delays and improve patient safety.
Learn more about E&L testing for inhalation and nasal drug products where ResolveMass excels in addressing volatile and semi-volatile impurities.
2. Medical Devices
Medical devices that go inside the body face high safety demands. Materials like plastics, glues, or coatings can release chemicals under heat or body fluids. These extractables can pose serious health risks if not identified and controlled early in the development process.
We simulate real-world use — such as body contact or sterilization — to test how your device behaves under stress. Our results help you stay compliant with FDA and ISO 10993-18 standards.
3. Packaging and Contact Materials
Packaging may look simple, but it can greatly affect drug safety. Plastic bags, blister packs, and glass containers can all release extractables over time, especially under heat or humidity. These interactions can compromise product stability, leading to reduced shelf life or potential patient harm.
We run tests that mimic extreme storage or transport conditions. This gives a clear view of what could leach into your product and helps keep your packaging compliant and safe.
Visit our Extractables and Leachables Testing page to explore material-specific testing strategies.
ResolveMass Laboratories: Experts in Custom E&L Testing
Industry-Leading Experience
Our team has supported hundreds of regulatory filings across the globe. From study design to final documentation, we’re with you every step of the way. Our collaborative approach ensures your data is accurate, submission-ready, and aligned with current regulatory expectations.
We combine expertise in chemistry, toxicology, and regulations to deliver detailed, dependable results. Clients trust us because we focus on both accuracy and strategy.
ISO-Certified Lab Standards
Our labs follow strict GMP and GLP procedures and are ISO-certified. Every test is backed by strong documentation and quality checks. This ensures that your data holds up during audits and inspections. We maintain full traceability throughout the testing process to support transparency and regulatory confidence.
We continuously update our methods to stay current with global standards and agency requirements.
Protocols Designed by Regulatory Scientists
All our testing begins with a careful risk review done by experienced scientists. We customize the protocol based on how your product is used and what it’s made from.
Your report will include method validation, impurity tracking, and full toxicological review. Every detail is reviewed by experts to ensure it’s accurate and complete.
Get detailed information about the cost of extractables and leachables testing so you can plan your compliance budget effectively.
Our Step-by-Step Process for Custom E&L Testing
1. Material and Risk Review
We look at the materials, how the product is used, and where it’s delivered in the body. This helps us choose the right tests and avoid unnecessary ones. A focused risk assessment at this stage ensures that testing is both efficient and scientifically justified.
2. Extraction Planning
We use stress conditions like high heat and strong solvents to force out potential leachables. This gives us a full picture of what could migrate from your materials. These worst-case scenarios help simulate long-term storage or extreme usage conditions. By uncovering potential risks early, we help you prevent surprises during regulatory review or product use.
3. Analytical Testing
Our lab uses advanced tools like GC-MS, LC-MS, ICP-MS, and FTIR. Each test is chosen based on your material’s chemistry to find even trace levels of extractables. These instruments allow for high sensitivity and specificity, ensuring no critical compound is overlooked. This level of detail supports both product safety and smooth regulatory approvals.
4. Toxicological Risk Assessment
Our team evaluates every substance we find and compares it against global safety limits. The final report supports your product submission with detailed risk data. We follow guidelines like ICH M7, PQRI, and ISO 10993-18 to ensure comprehensive toxicological assessments. This process helps demonstrate the safety of your product and builds confidence with regulatory agencies.
Visit our E&L testing cost page to see how our solutions fit your timeline and budget.
Industries That Benefit from Custom E&L Testing
We offer specialized testing for:
- Pharmaceutical companies
- Biotechnology developers
- Medical device manufacturers
- Combination product innovators
- Packaging and container suppliers
- Nutraceutical and supplement producers
Each sector has unique materials and risks. Our flexible approach ensures we meet your specific needs.
Our Promise: Reliable Data and Full Compliance
At ResolveMass, we go beyond testing. We’re a trusted partner that helps you meet your compliance goals.
Our detailed reports include all necessary documentation, test data, and regulatory references. Whether you’re preparing for FDA, EMA, or other global submissions, we make sure your testing meets the mark.
If you’re working on complex projects with unique materials, we invite you to schedule a discussion through our Contact Us page to get started on a customized testing strategy.
Getting Started with Custom E&L Testing
Step 1: Share your materials, drawings, and product overview.
Step 2: Receive a detailed testing plan within 48 hours.
Step 3: Begin testing with clear milestones and regular updates.
Need fast results or support with a submission? Our team is here to help.
Conclusion: Stay Ahead with Custom E&L Testing
Regulations are getting tougher, and product designs are more complex than ever. That’s why Custom E&L Testing from ResolveMass is the smart choice. Our tailored programs help you meet global safety standards, avoid delays, and build confidence in your product. By identifying risks early, we help streamline development and reduce costly rework. Partnering with us means gaining a trusted team committed to your success from start to finish.
Whether it’s a new injectable, device, or packaging system — we have the tools, expertise, and dedication to support your success.
Visit our Extractables & Leachables Testing page or contact us today to get started.
FAQs
Regulatory agencies like the FDA and EMA require product-specific data to ensure patient safety. Custom E&L Testing helps identify harmful substances that could migrate into the product from containers or devices. This proactive approach reduces risk, supports smoother approvals, and builds confidence in your product’s safety profile.
The typical timeframe for Custom E&L Testing ranges from 6 to 14 weeks, depending on the product complexity, number of samples, and regulatory requirements. For urgent needs, expedited testing services are available. We also offer milestone-driven reporting to keep your team informed throughout the process.
Our lab uses advanced tools such as GC-MS, LC-MS, ICP-MS, and FTIR to detect and identify extractables and leachables. Each technique is selected based on the material type and expected chemical profile. This ensures precise results, even for trace-level compounds that could pose long-term risks.
Our testing protocols are aligned with major global standards, including FDA, EMA, USP <1663>/<1664>, ICH Q3E, and ISO 10993-18. We also stay current with industry-specific expectations for pharmaceuticals, biologics, and medical devices. This ensures your data is ready for global submissions and audits.
Costs vary based on sample type, number of tests, regulatory scope, and reporting requirements. We provide transparent pricing with detailed proposals tailored to your needs. For budget planning, you can visit our pricing page or request a quote through our Contact Us form.
Yes, we offer expedited testing options for clients with tight deadlines or urgent submission needs. This includes parallel workflows, fast-tracked documentation, and priority access to lab resources. Our team works with you to ensure speed without compromising quality or compliance.
Absolutely. Our reports are designed to meet the requirements of global regulatory agencies including the FDA, EMA, PMDA (Japan), Health Canada, and others. We tailor the format and content to align with your target markets, ensuring your submission is well-supported and compliant.
