Tara Lin Couch, Ph.D. is an Analytical/Organic Chemist who also possess a B.S. in Mathematics. Dr. Couch has exceptional analytical abilities and more than 35 years of diverse laboratory and regulatory experience in academic, field, contract and manufacturing environments. She is a sought-after expert on issues pertaining to quality control in pharmaceutical, dietary supplement, tobacco manufacturing, and the cannabis industries. As a consultant, Dr. Couch assists with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical and compliant with FDA regulations. To evaluate this regulatory compliance, she performs mock FDA inspections, gap analyses, and contractor and laboratory audits to Current Good Manufacturing Practices (cGMPs) and other applicable statutory requirements. She also helps clients with the conduct of FDA regulatory surveillance, follow-up, and pre-approval inspections including preparation efforts, direct support, and responding to FDA related communications such as the initial Form 4003 – Inspection Records Requests, Form 483 - List of Observations, Warning Letters, Consent Decrees, Deficiency Letters, and other information requests. In addition, Dr. Couch provides cGMP and laboratory trainings via seminar, webinar and on-site presentations.
Dr. Couch earns the respect of colleagues and loyalty of clients with her unwavering commitment to quality, exceptional work ethic, and use of her vast experience to thoughtfully create a pragmatic, customized compliance strategy for each client.