Not Another Consultant. Your Regulatory Partner.

Mederi provides senior regulatory strategy to emerging pharmaceutical and biotechnology companies, helping teams make the critical development decisions that shape successful programs. From early regulatory planning and FDA interactions through marketing application strategy, we serve as an experienced regulatory partner, providing executive-level guidance tailored to each stage of development.

Whether you need strategic leadership for an entire development program or targeted support for a specific regulatory milestone, Mederi delivers practical, science-driven advice backed by decades of experience bringing ophthalmic therapies through the regulatory process.

  • Regulatory Strategy Advising

    Regulatory Strategy Advising

    Mederi provides strategic, science-driven regulatory guidance from development through approval—helping clients define pathways, design clinical programs, and navigate FDA interactions for successful outcomes.

  • FDA Meetings Coordination

    FDA Meetings Coordination

    Mederi prepares you for every step of the FDA meeting process—from strategy and briefing documents to rehearsals and follow-up—ensuring productive interactions andstrong regulator relationships.

  • IND Management + Regulatory Operations

    IND Management + Regulatory Operations

    From IND to NDA, Mederi provides full regulatory support with clarity and efficiency. We manage submissions, health authority interactions, and ongoing maintenance—backed by a network of trusted experts—so you can stay focused on development.

  • Publishing

    Publishing

    Mederi handles regulatory publishing in-house for faster, seamless submissions. From INDs to NDAs, we ensure compliance, proper formatting, and timely delivery— reducing handoffs and keeping your team focused on development.

  • Medical Writing

    Medical Writing

    Mederi delivers clear, compliant medical writing for key regulatory documents—from protocols and IBs to DSURs and study reports. With deep expertise and strategic focus, we align with FDA expectations and communicate your science with precision.

Ready to Move Forward with Confidence?

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

CONTACT US

  • Kristin is the ultimate professional in regulatory consulting and operations. She and I have done many projects together and her commitment, conscientiousness, creativity, and logical thought process have excelled in delivering great outcomes in complicated scenarios. She’s a wonderful person and an excellent regulatory expert.

    George Magrath, MD, CEO, Opus Genetics

  • Kristin is an outstanding professional with specific strengths in regulatory affairs matters in ophthalmology. Kristin in smart, diligent and conscientious. I highly recommend Kristin to anyone seeking regulatory and quality assurance support and consultation.

    Chad Ice, Co-Founder and Former CEO, Lexitas

  • Kristin is not only an expert in regulatory affairs but possesses rich and deep experience in ophthalmology. She's a “go to” expert who is also kind, responsive, and of the highest integrity and ethics.

    Jeanette Stewart, Co-Founder and Director at PRN Pharmaceutical Research Network

  • I’ve had the privilege of working with Kristin for over 15 years. Kristin is an exceptional “go to” resource for quality and regulatory affairs support related to US and international research, especially for ophthalmology. Her knowledge, experience, and ability to quickly assess risk has proven invaluable.

    Kristie Veasey, Executive Director, Clinical Development, KALA BIO

  • I am fortunate to have worked with Kristin on multiple critical programs in ophthalmic drug development where we needed top flight regulatory support. Kristin has not only delivered what we needed, she has done so as an active and collaborative team member helping us all optimize clinical development strategy, clin ops, and regulatory interactions. Her guidance is well informed, she is easy to work with and as is needed in these situations, Kristin is well organized and has kept us on timelines ensuring all documents are finalized and ready on schedule. Furthermore, Kristin is knowledgeable, experienced, and responsive, and she demonstrates an excellent working relationship with Agency personnel. Not only is Kristin reliable and effective within our group, she represents our company and team admirably with the Agency. I highly recommend Kristin for regulatory consulting services.

    Dave Kleinman, Ophthalmic drug development consultant and early-stage company CEO