Learn Suttons Creek’s Story
Meet Our Combination Product SpecialistsTrust in Our 650+ Combined Years of Device and Combination Product Experience
SUPPORTING PHARMA’S COMBINATION PRODUCTS SINCE 2012
PURPOSE: Built to be Pharma’s outsourced partner of choice with deep experience with the Combination Product value chain
TEAM: Recruited from the Combination Product industry
- 80+ subject matter experts from Pharma, Device OEM’s and regulatory bodies
- Four former FDA / CDRH lead Reviewers
- Global experience and history working with EU notified bodies
TRACK RECORD:
Successful launch of 120+ drug and biologic delivery devices
80+ big and small pharma clients led to success
We’ve successfully supported the development of over 120 individual drug and biologic delivery systems, covering a variety of systems including: Auto Injectors, Pre-Filled Syringes, On-Body Devices, Inhalers, Lyo-Kits, Attached Bio-Sensors, Vial Adaptors, Adherence Support, Predictive Modeling Platforms.
Founded by CEO, Steve Badelt, Phd, and having engaged with pharma since before the FDA’s combination product ruling, Suttons Creek is uniquely positioned as the industry’s premier delivery device managed services and corporate advisory firm. With a roster of globally experienced, specialized consultants, Suttons Creek supports clients from concept to deployment through the complex regulatory approval process.
Thanks to the 2024 acquisition of Suttons Creek into the BlueRidge Life Sciences family of best-in-class companies, partnering with Suttons Creek means access to even more experts to solve the multifaceted problems and challenges faced by our life sciences clients.
Learn more about how Suttons Creek’s experts can support your combination product project by clicking on expert bios below and visiting our Services page.
To begin a conversation on how our experts can support your team, simply fill out our online contact form or call us directly at 877.611.4724.
Our Team is Your Team
Meet the leadership of Suttons Creek. They set strategies and manage teams of talented combination product experts, hand-selected to provide the specialty subject matter expertise needed to make your project a success and support your corporate goals.
Steve Badelt, PhD
Executive Vice President and Managing Partner
Rob Schulz, RAC
Senior Vice President
David Urban
VP of Sales, Marketing, & Business Development
Carolyn Dorgan
Vice President, Solutions Engineering
Paul Chao
Vice President, Solutions Engineering
Jonathan Amaya-Hodges
Consulting Director
Albana Thorpe
Director, Technical Services
Konrad Walzer
Director, Technical Services
Mickey Burg
Associate Director, Program Management
Karen Keeley
Senior Director of Sales – West
Jennifer Engels
Director of Sales – East
Bryan Bobo
Associate Technical Director
Max Lerman, PhD
Associate Director, Solutions Engineering
Read Bio
Nina Provenzano
Human Resources Manager
Glenn Empey
Sr. Principal Consultant
Courtney Evans
Principal Consultant
Jeff Kim
Senior Principal Consultant & Associate Director of Quality Systems
Jin Kim
Sr. Project Manager
Parth Kothari
Senior Principal Consultant
Michael Koucky
Principal Consultant
Kenny Lin
Principal Project Manager
Sarah Mollo, PhD
Principal Consultant
Katherine Nishimoto
Senior Project Management Consultant
Andrew Ozga
Senior Consultant
Brian Pullins
Senior Project Management Consultant
Jasiah Sta. Maria
Senior Consultant, Systems Engineering
Diane Reed
Principal Consultant, Regulatory Affairs
Alex Spivak
Principal Consultant
Alan Wang
Principal Consultant
Kelly Wedig
Principal Consultant
Suttons Creek is a proud member of the BlueRidge Life Sciences family of companies.
Suttons Creek is a member of the following industry organizations, providing us numerous opportunities to continually build upon our knowledge-base and industry relationships, as well as affect change in the regulatory landscape for combination products.
