Comprehensive E&L Studies Ensuring Regulatory Compliance Worldwide
At Indivirtus Healthcare Services Pvt. Ltd., our specialized Extractables and Leachables (E&L) Testing services help you identify and quantify potentially harmful substances that may migrate from packaging or delivery systems into your pharmaceutical products. Using industry-leading ISO 10993-18 standards and advanced analytical techniques like GC-MS and LC-MS/MS, we deliver reliable safety data and complete regulatory compliance to support your global market submissions.
Our comprehensive services include developing customized E&L study protocols, creating detailed extractables profiles, conducting leachables testing under real-world conditions, and providing toxicological risk assessments that ensure full compliance with international regulatory standards.
E&L testing is crucial for protecting patient safety, ensuring your drug formulations remain stable and effective, and meeting strict regulatory requirements by identifying any potentially harmful substances that could migrate from packaging or delivery systems into your products.
As your trusted testing partner, Indivirtus Healthcare Services provides scientifically rigorous E&L solutions delivered by experienced professionals, giving you the accurate, submission-ready data needed to achieve successful product development and secure global market approvals.
At Indivirtus Healthcare Services, our Extractables and Leachables Testing services are managed by certified analytical chemistry and toxicology specialists with extensive international regulatory experience. We develop tailored study protocols specific to your products and utilize advanced analytical methods including GC-MS and LC-MS/MS to accurately detect and quantify extractables and leachables under conditions that mirror real-world product use.
Our systematic approach delivers submission-ready reports that fully comply with ISO 10993-18, USP <1663>/<1664>, ICH Q3D, and FDA Container Closure Guidelines, providing you with the confidence needed to support pharmaceutical safety claims and regulatory compliance worldwide.
Customized E&L Study Protocol: Comprehensive testing plan designed specifically for your extractables and leachables evaluation needs.
Advanced Extractables Profile (GC-MS/LC-MS/MS): Detailed analytical characterization of all potential extractable compounds from your materials.
Realistic Leachables Assessment Report: Complete leachables data generated under simulated real-world use conditions for regulatory submissions.
Professional Toxicological Risk Assessment: Expert safety evaluation of identified substances when required for comprehensive risk analysis.
Our E&L Testing services strictly follow the most rigorous international standards and guidelines, ensuring your data meets global regulatory expectations and is immediately ready for submission. By maintaining compliance with industry-leading requirements, we provide testing solutions that build regulatory confidence while ensuring the highest levels of product safety and quality.
Our specialized E&L Testing services serve pharmaceutical manufacturers and medical device companies who need to ensure complete product safety and achieve regulatory compliance. Perfect for evaluating packaging systems, drug delivery devices, and medical equipment, our solutions support successful global regulatory submissions. Primary applications include comprehensive packaging compatibility assessment, detailed leachables evaluation for regulatory documentation, and thorough safety verification for combination drug-device products.
Indivirtus Healthcare Services stands as the preferred testing partner for pharmaceutical and medical device companies worldwide, providing expert-driven E&L testing solutions supported by certified analytical and toxicology professionals with proven global regulatory experience. Our comprehensive services guarantee scientifically sound results, efficient project delivery, and complete confidentiality to safeguard your valuable proprietary information.
Through our unwavering commitment to industry excellence and best practices, we empower your organization with compliant, robust E&L data that drives successful regulatory outcomes while ensuring the highest standards of patient safety and product quality.
Extractables are chemical compounds that can be released from packaging materials or medical devices under controlled laboratory conditions using aggressive solvents. Leachables are the actual compounds that migrate into drug products during normal storage and use conditions. Both must be carefully evaluated to ensure complete patient safety and product integrity.
The primary guidelines include ISO 10993-18 for medical device materials, USP <1663> and <1664> for pharmaceutical packaging, and ICH Q3D for elemental impurities. These comprehensive standards provide detailed methodologies for E&L characterization, toxicological risk assessment, and establishing acceptable exposure limits for patient safety.
We employ a comprehensive suite of analytical methods including GC-MS (Gas Chromatography-Mass Spectrometry), LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry), ICP-MS (Inductively Coupled Plasma-Mass Spectrometry), and FTIR (Fourier Transform Infrared Spectroscopy), selecting the most appropriate techniques based on the expected chemical nature of extractables and leachables in your specific test matrix.
Yes, we offer complete toxicological risk assessment (TRA) services for all identified leachables. This includes determining potential patient health risks, comparing detected levels against established safety thresholds, and providing expert recommendations on whether concentrations exceed permitted regulatory limits for your specific application.
Absolutely. We design customized simulated-use protocols that accurately reflect real-world conditions, including appropriate solvent systems, realistic temperature ranges, and proper time durations based on your intended drug product usage patterns. This ensures our leachables assessment truly represents what patients might be exposed to during actual product use.
Our complete E&L testing services include developing customized study protocols tailored to your specific products, comprehensive extractables profiling using advanced analytical methods, detailed leachables testing under realistic simulated-use conditions, and professional toxicological risk assessments when required for complete safety evaluation.
Pharmaceutical manufacturers, medical device companies, biopharmaceutical organizations, and injectable drug product developers all benefit significantly from our specialized E&L testing solutions. Any company developing packaging systems, drug delivery devices, or combination products requires these services for regulatory compliance and patient safety assurance.
Our comprehensive services strictly align with all major international standards including ISO 10993-18, USP <1663>/<1664>, ICH Q3D, and FDA Container Closure Guidelines. This ensures your testing data meets global regulatory expectations and is immediately ready for submission to authorities worldwide, providing confidence in your regulatory strategy.
Clients receive comprehensive customized E&L study protocols, detailed extractables profiles with complete analytical data, thorough leachables reports under simulated-use conditions, and professional toxicological risk assessments when required. All deliverables are prepared to meet regulatory submission standards and include expert interpretation of results.
Yes, our E&L testing services are completely tailored to your unique packaging systems, delivery devices, and specific regulatory requirements. We work closely with your team to understand your product characteristics, intended use conditions, and regulatory pathway to ensure our testing approach delivers exactly the data you need for successful submissions.
We provide submission-ready E&L reports and comprehensive risk assessments that directly support safety data requirements for pharmaceutical and medical device regulatory filings. Our reports include detailed methodology, complete analytical results, expert data interpretation, and clear conclusions that regulatory authorities expect to see in successful applications.