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Understanding safety and performance requirements for medical device submissions White Paper

Understanding safety and performance requirements for medical device submissions
06/11/24
Getting Ahead of Industry Expectations for Biological Therapeutics Testing Article

Getting Ahead of Industry Expectations for Biological Therapeutics Testing
04/10/24
ISO 10993-18: An Introduction to Chemical Characterization of Medical Devices Webinar

ISO 10993-18: An Introduction to Chemical Characterization of Medical Devices
04/08/24
Characterization of adhesive related leachable deriving from medical infusion bag. Case Study

Characterization of adhesive related leachable deriving from medical infusion bag.
02/22/24
Exploring Extractables & Leachables studies for Orally Inhaled and Nasal Drug Products (OINDP) to ensure delivery system compliance Webinar

Exploring Extractables & Leachables studies for Orally Inhaled and Nasal Drug Products (OINDP) to ensure delivery system compliance
01/03/24
Assessing extractables & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term storage. Webinar

Assessing extractables & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term storage.
12/01/23
The implementation of USP 665 and BPOG White Paper

The implementation of USP 665 and BPOG
11/01/23
Risk-based approach to E&L studies for single use manufacturing systems within biopharma White Paper

Risk-based approach to E&L studies for single use manufacturing systems within biopharma
07/24/23
The Importance of the Analytical Evaluation Threshold (AET) in Extractable and Leachable Studies Blog Post

The Importance of the Analytical Evaluation Threshold (AET) in Extractable and Leachable Studies
07/12/23
The Rise of Chemical Characterization Testing for Medical Devices Blog Post

The Rise of Chemical Characterization Testing for Medical Devices
07/12/23
Poly and Perfluoroalkyl Substances (PFAS): Answering your most Frequently Asked Questions Article

Poly and Perfluoroalkyl Substances (PFAS): Answering your most Frequently Asked Questions
06/01/23
Extractables and Leachables Liquid Extraction Method: eBook White Paper

Extractables and Leachables Liquid Extraction Method: eBook
05/26/23