Expert Support for Your Combination Products Needs
Experienced Consulting for your end-to-end pre- and post-market combination product needs.
Our experts understand the interactions between medicinal products (drugs/ biological products) and medical devices and the associated quality and regulatory expectations.
Combining drugs, devices, and/or biologics brings many benefits to patients, but also brings technical, quality and regulatory challenges. We're here to help!
About Susan Neadle
Susan Neadle, MS, BS, FRAPS, FAAO, is a globally recognized expert in Combination Products and Medical Devices, bringing over 35 years of industry experience. She’s known for her leadership, innovation, and active involvement across global regulatory, quality, and educational forums. Her work has earned her numerous accolades, including the RAPS Fellowship, the 2022 ISPE Joseph X. Phillips Professional Achievement Award, and the prestigious Johnson Medal from Johnson & Johnson, where she led an impactful career before founding her consultancy.
Now Principal Consultant at Combination Products Consulting Services LLC, Susan continues to influence the industry through executive advisory, regulatory, and quality support. She’s also the author of The Combination Products Handbook: A Practical Guide and serves as Chair of AAMI's Combination Products Steering Committee. Susan teaches and speaks widely, supporting standards development and workforce education.
1st Edition The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems Edited by Susan Neadle (c)2023.
Contributing Authors: John Barlow Weiner (FDA Office of Combination Products); Susan Neadle (CP Consulting Services)(retired, Johnson & Johnson); Suzette Roan (Sanofi); Mike Wallenstein (Novartis); Rick Wedge (Pfizer); Ed Bills (Ed Bills Consulting); Shannon Hoste (Agilis); Stephanie Canfield (Agilis); Bjorg Hunter (Novo Nordisk); Theresa Scheuble (Johnson & Johnson); Kim Trautman (MediCept); Meera Raghuram (Lubrizol); Fran DeGrazio (retired, West); Jennifer Riter (West); Daniel Bantz (retired, West); Manfred Maeder (Novartis); Stephanie Goebel (Beyond Conception GmbH); Viky Verna (Confinis); Cherry Marty (Confinis); Dhiraj Behl (PPD)
Get the expert guide trusted by regulatory and quality professionals worldwide. Grab your copy of The Combination Products Handbook today and elevate your product development strategy.