Regulatory Requirements for Assay Validation and Approval
Navigating the intricate web of regulatory requirements for assay validation and approval can be challenging.
Jane Johnson is a highly experienced regulatory affairs professional with over 15 years of experience in the pharmaceutical and biotech industries. She has extensive knowledge of regulatory requirements for assay validation and approval, and has helped numerous companies successfully navigate the regulatory approval process for their diagnostic and clinical trial assays. Surmodics’ leadership in surface technologies dates to our development of the drug-delivery coating for the first drug-eluting stent. Since then, we’ve consistently pioneered breakthrough lubricious, hemocompatible, and drug-delivery COATINGS for the world’s leading medical device companies.
Navigating the intricate web of regulatory requirements for assay validation and approval can be challenging.