Navigate the Regulatory Landscape with Mederi

Mederi specializes in simplifying the complex world of regulatory affairs in the pharmaceutical industry. We provide clients with Pre-IND consultations, help with IND submissions, schedule and facilitate meetings with the FDA, interpret feedback, and organize review meetings. Furthermore, Mederi assists with CT.gov reporting requirements and services related to Orphan Drug Designation.

  • IND Submissions

    IND Submissions

    Mederi can help you navigate the regulatory landscape with confidence by entrusting us with your IND submissions. Our expert team is dedicated to helping you through the entire process. From engaging and working with publishers, to organizing review meetings, we help you every step of the way.

  • FDA Meetings

    FDA Meetings

    Meetings with the FDA are complex, challenging, and require significant preparation and follow-up efforts. From understanding what type of meeting is required, or if written responses are sufficient, to conducting the meeting, to required follow-up, Mederi can help orchestrate meetings and interactions to address regulatory concerns, seek feedback, and ensure alignment with regulatory expectations throughout the product development lifecycle.

  • Medical Writing

    Medical Writing

    Our medical writers are experts in scientific communication who can translate complex data into easy-to-understand information for regulatory submissions. Mederi’s medical writing services include clinical trial protocols, clinical study reports, DSURs, IND Annual Updates, and investigator brochures.

  • Pre-Ind Consultations

    Pre-IND Consultations

    Mederi experts can help you gain valuable insights that pave the way for a seamless regulatory process, ensuring your pharmaceutical endeavors start on a path to a successful IND. We can help you schedule and facilitate a pre-IND meeting with the FDA. If you’ve already had this meeting, we can help you understand the Agency’s feedback and how that affects your program designs.

  • Clinic Trials

    ClinicalTrials.gov

    CT.gov reporting requirements are complex and nuanced. If you have questions about your obligations or would simply prefer to delegate this regulatory requirement, we can help. This includes original submissions, maintenance, and results reporting.

  • Orphan Drug Designations

    Orphan Drug Designations

    Harness regulatory advantages for rare disease treatments with our Orphan Drug Designation services. From submissions to annual updates, we specialize in assisting your company to secure orphan designation status, providing your groundbreaking therapies with the recognition and support they deserve.

  • 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, Ocuphire

  • Kristin Williams 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.

    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

  • 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

  • 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