Founder

Mederi, Inc. was founded by Kristin Hanley, JD. Kristin is an attorney and regulatory strategist with nearly two decades of experience supporting ophthalmic drug development. Throughout her career, she has advised sponsors on critical regulatory decisions, FDA interactions, development strategy, quality systems, and submission planning. Kristin formerly served as the Vice President of Quality and Regulatory Affairs at Lexitas Pharma Services, Inc., and as one of Lexitas’s first employees built the quality and regulatory departments from the ground up.  Kristin specializes in helping clients understand and navigate the complex regulatory processes necessary for drug approval. Prior to her ten years at Lexitas, Kristin worked at Inspire Pharmaceuticals with several marketed and investigational products.

Kristin is a NC-licensed attorney and a patent attorney, holding a Juris Doctor and Master of Jurisprudence in Health Law from Loyola University Chicago.  She is also RAC certified and holds multiple data protection certifications.