Extractable and Leachable Studies

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We provide tailored E&L studies of pharmaceutical, biologic, medical device, reduced risk, combination products, and more in order to meet regulatory requirements for route of administration, formulation, dosage, the standards for medication delivery devices, container-closure systems, and more, all while ensuring patient safety and reducing time to market. The safety or efficacy of the completed product may be impacted by potentially dangerous organic and inorganic pollutants that may have migrated into it from container-closure systems, manufacturing components, process equipment, packaging, or delivery devices. The largest healthcare brands in the world collaborate with the regulatory and scientific experts at MedWatch Global to evaluate the products’ patient safety. The cornerstones of the market-leading, comprehensive E&L solutions we provide are a thorough understanding of regulatory requirements, from materials assessment to toxicological evaluations, decades of experience developing and implementing extractable and leachable programmes, one of the largest extractable databases in the industry, and a track record of successful support for complex dosage forms.

Extractable and Leachable Regulatory expectations:

E&L data must be submitted with every biologics license application (BLA) and new drug application (NDA), according to regulatory organizations like the FDA and DRAP. However, despite the fact that the FDA and DRAP have offered basic recommendations about the methodology and requirements for E&L testing, the procedures are not prescriptive. It’s essential to have a full understanding of permissible protocols and reports because using the wrong one can cause expensive delays, especially for biopharmaceutical regulatory submissions that call for packaging safety and toxicological investigations. The key regulatory information source ISO 10993 must also be thoroughly understood in order to appropriately analyze requirements for combination products and medical devices in order to successfully create and deliver an extensive extractable and leachable testing programme.

Our services:

  • Extractables & Leachables Regulatory Guidance Services
  • Extractables & Leachables Training Services
  • Extractables & Leachables Testing Reports
  • Streamlining Extractables & Leachables Testing Protocols
  • Biocompatibility Analysis for Breathing Gas Pathways