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Two New Regulatory Experts Bringing Unique Perspectives to the Suttons Creek Team


Applying cGMPs for Combination Products to Ophthalmic Devices

Suttons Creek is very happy to announce the recent addition of two new and talented combination product specialists to our team. Max Lerman, PhD and Rita Lee, PhD RAC have joined Suttons Creek as Principal Consultants, combination product regulatory affairs experts that will lead client projects for our Technical Services team overseen by Rob Schulz (President, COO) and Technical Directors, Carolyn Dorgan and Jonathan Amaya-Hodges. Both Max and Rita have extensive regulatory experience that will bring even more strength to our talented group of combination product regulatory specialists who possess in-house pharma experience, and our EU team members who are registered consultants with notified bodies. 

With over three years at the FDA as a member of the infusion devices team, Max has deep experience in developing and setting review practices for infusion, life-critical drug delivery, and electroporation systems and was also a member of AAMI ID and IP infusion pump committees. Prior to the FDA, he spent over two years at Medtronic developing and maintaining electrocautery platforms. Max’s industry experience, insider FDA knowledge, and the specialized education he received while earning his Masters of Science and Doctor of Philosophy in Materials Science and Engineering at the University of Maryland, College Park provided him the knowhow to go on to author 11 peer-reviewed publications, 17 conference presentations, and 3 patent submissions  (to date). This know-how will also be critical support to Suttons Creek clients and their combination product development and regulatory approval success.

Rita’s 15+ years of practical involvement in Regulatory Affairs has afforded her significant experience interfacing with FDA in a variety of circumstances concerning devices and combination products, with a focus on drug delivery. She has guided medical device and combination product regulatory strategy for numerous products, including infusion pumps (pre-filled and user-filled), bioelectronics, mobile apps, in-vitro diagnostics (IVD), and inhalation devices (nebulizers, DPI). With a PhD in biology (with research in genetics) from Syracuse University and an impressive job history which includes time as a medical/technical writer and work as both a Regulatory Scientist and Director of Regulatory Affairs for United Therapeutics Corp. (UTC), Rita has developed a strong knowledge of inhalation devices and effective regulatory and medical writing skills that, among many other talents and specialties, which are an exciting and substantial addition to our existing team’s expertise.

We are extremely proud that the Suttons Creek team continues to attract top talent and industry-leading clients.  We look forward to more announcements like this in the new year as we continue our growth.

To learn more about Rita and Max or connect with them via LinkedIn or email, check out their profile page on our website: Rita Lee, PhD, RAC | Max Lerman, PhD

Fill out our online contact form to set up a meeting to explore how Rita and Max can support your Regulatory Affairs efforts.