Combination Product Development

Whether you’re at the beginning of your combination product or software development, or in the middle of the clinical phase of your pharmaceutical development lifecycle and preparing for commercialization and your regulatory filing… we can help.

We Build Combination Product Systems to Work With—and Within—Your Existing Systems

Our adaptive approach allows us to be the architects of customized documentation so you can improve your systematic processes and get the job completed in a compliant and efficient manner.

One of the most common questions pharmaceutical companies ask is “how can you help us with our Combination Product?”

Fundamentally, the answer lies with you. What are you looking to achieve? Why do you to believe that you need support? What is missing or occurring that you have questions about?

For each client, those answers—and our engagement model—may be different. Collaboration might begin at the starting line of your combination product or software development, or it might being during the clinical phase of your pharmaceutical development lifecycle to prepare for commercialization and the regulatory filing.

Regardless of where you are in your development and decision making process, starting the conversation is what matters.

“Suttons Creek strikes the right balance between attention to detail and a systems-level approach.”
Bohdan Oppenheim, PhD, INCOSE

Trust in Our 230+ Combined Years of Device and Combination Product Experience

We’ve worked on 45 individual client projects covering over 45 drug delivery systems including:
  • Auto Injectors
  • Pre-Filled Syringes
  • On-Body Devices
  • Inhalers
  • Lyo-Kits
  • Attached Bio-Sensors
  • Vial Adaptors
  • Adherence Support
  • Predictive Modeling Platform

Combination Product Assessments

Suttons Creek understands the hurtles that all pharmaceutical companies face – big or small – which is why we really appreciate when clients seek out our expertise at varying stages of their combination or software development. An initial assessment can help your team to make the right decision about your next steps and ensure success in the combination product market.

Our combination product assessment will give you an expert vantage point to see solutions to development or quality challenges. By integrating our engineering, quality, and regulatory expertise—we can help you understand the challenges you face—and develop a plan to meet them.


As the definition of Software as a Medical Device [SaMD] evolves, so can the confusion as to what really comprises a medical device. We can support you with determining classification, identifying potential partner vendors and suppliers, and determining the optimal time for you to begin development of your QMS system to support your SaMD.