INTRODUCTION The future of Extractables and Leachables (E&L) testing is being reshaped by AI, automation, and advanced CRO service models—and […]
Future of Extractables and Leachables (E&L) Testing: AI, Automation, and CRO Services Read More »
Introduction Extractables and Leachables (E&L) in Emerging Biologics and Advanced Therapies represent one of the most critical product-safety concerns in
Extractables and Leachables (E&L) in Emerging Biologics and Advanced Therapies Read More »
INTRODUCTION Extractables and Leachables (E&L) Requirements for U.S. Market Authorization are central to ensuring that materials contacting drug products do
INTRODUCTION Selecting a partner for Extractables and Leachables (E&L) Testing in the United States is one of the most important
INTRODUCTION Outsourcing to a U.S.-based Extractables and Leachables (E&L) testing laboratory in the United States helps pharmaceutical and biotech companies
Choosing the right ICH Q3E Extractables & Leachables (E&L) Testing Laboratory is one of the most important decisions a sponsor
Introduction The new guideline ICH Q3E Extractables & Leachables (E&L) for Medical Devices represents a major step toward global alignment
ICH Q3E for Medical Devices and Combination Products: How E&L Requirements are Evolving Read More »
INTRODUCTION The ICH Q3E Extractables and Leachables (E&L) study requirements outline a unified regulatory expectation for evaluating chemical migrants from
The ICH Q3E Extractables & Leachables (E&L) Risk Assessment provides a global structure to ensure that materials, components, and manufacturing
ICH Q3E Extractables and Leachables (E&L) Testing Services are essential for showing that packaging materials, device parts, and manufacturing components
