Extractables and Leachables US sponsors and exhibitors are leaders in the field. During the event, they present innovative products and services to an audience of key decision makers looking for ways to enhance their business.
For more information on how you can put your company in front of the right E&L experts at this event, reach out to Steve Frier at SFrier@smithers.com or visit the Sponsorship page.
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Element delivers tailored E&L studies of pharmaceutical, biologic, medical device, combination products and more. Element's global E&L service offerings brings together capabilities across Europe and North America, including services offered at Bend.
Partner with the E&L experts at Element Bend to meet regulatory expectations and overcome hurdles on the most efficient path to gaining regulatory approval while cutting costs and reducing time to market.
Gad Consulting Services (GCS) has been providing expert toxicology services to pharmaceutical and medical device companies for over 30 years. We have experience with drugs, devices, and combination products in numerous therapeutic areas, throughout all stages of development and for those already on the market. GCS is proud to offer toxicology and biocompatibility support tailored to meet the specific needs of our clients. Consulting services include:
· Regulatory strategy development; design of full non-clinical and biocompatibility testing programs;
· Medical device gap assessments, biological evaluations, change assessments, bioequivalence determinations
· Study placement and monitoring, report review and preparation, lab audits;
· IND writing, preparation, and filing
· Interaction with regulators, including response to deficiencies without previous project involvement;
Our team has extensive experience in toxicological risk assessment (TRA) methods including the estimation of acceptable exposure limits, and the application of (Q)SAR methodology. Gad Consulting is well-known for the quality and consistent regulatory acceptance of our reports on:
· TRA of medical device extractables, leachables, and volatile organic substances (ISO 10993, ISO 18562)
· TRA of drug packaging and manufacturing equipment extractables and leachables (ICH Q3)
· Qualification of impurities, degradants, residual solvents, and excipients (ICH Q3)
· Mutagenicity evaluation and calculation of compound specific limits, including nitrosamines (ICH M7, (Q)SAR)
Why Choose Nelson Laboratories
Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
Companies choose Nelson Laboratories for our:
See how we can help you mitigate risk, be first to market, and succeed with your customers.
