Kristin Hanley, JD, RAC

Founder

Mederi, LLC was founded by Kristin Hanley, JD. Kristin is an experienced regulatory and compliance professional with over 15 years of experience in the pharmaceutical industry, most of which was dedicated to ophthalmology.  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 ophthalmic 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.

Our Team

Mederi’s team is made up of experienced regulatory professionals with deep ophthalmic expertise and a proven track record across the full drug development lifecycle. We combine strategic insight with practical execution to support clients from early development through approval.

In addition to our in-house regulatory and medical writing experts, we collaborate with trusted consultants in non-clinical/toxicology and CMC. This integrated model allows us to deliver seamless, end-to-end regulatory support—so you can stay focused on development while we manage the complexities.

Ready to Move Forward with Confidence?

Contact Mederi today and let’s take the next step in your regulatory journey—together!