Overview
FDA consulting addresses compliance with federal food safety, drug approval, medical device clearance, and cosmetics regulations. MDT Expert Consulting provides access to former FDA officials, regulatory affairs specialists, and quality systems experts who evaluate whether regulated companies met applicable FDA requirements in their development, manufacturing, labeling, and distribution of FDA-regulated products in warning letter responses, consent decree matters, and product liability litigation.
Pre-Litigation Support
Before litigation or in response to FDA enforcement action, FDA regulatory experts help counsel assess the nature and scope of compliance failures and evaluate available remediation strategies. They review FDA correspondence, inspection records, product files, and quality system documentation to develop an early assessment of regulatory exposure.
Litigation Support
In litigation, FDA experts assist in evaluating the adequacy of regulatory submissions, assessing whether manufacturing and quality control practices met applicable cGMP requirements, and providing context for the regulatory standards applicable to the products and conduct at issue.
Arbitration Support
FDA regulatory experts address commercial disputes in arbitration involving supply agreements, licensing arrangements, and manufacturing contracts for FDA-regulated products.