Please join Element at The Extractables & Leachables Summit, Sept. 20-21, 2022, at the Wyndham Philadelphia, Philadelphia, PA
Element has the most comprehensive extractables and leachables (E&L) practices in the world. We deliver tailored E&L studies of pharmaceutical, biologic, medical device, combination products and more, in accordance with regulatory expectations for route of administration, formulation, dosage, container-closure system and drug delivery device requirements, ensuring patient safety and expediting time to market.
About the event
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidance's & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.
Book a meeting
Schedule a meeting with one of our experts to learn more about how we can help you to develop better products, save time and money, and minimize potential risk to your business.
The Industries We Serve
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
On-demand Webinar: E&L Considerations for Customized Syringe Delivery
Dr. James Scull, Scientific Director for Element Life Sciences, discusses a case study that explores the E&L consideration of custom drug delivery systems in order to meet regulatory requirements.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.