Pharma's Device Team for Combination Products

We help bring drug/biologic + device products to market.

Pharma's Device Team for Combination Products

We help bring drug/biologic + device products to market.

Pharma's Device Team for Combination Products

We help bring drug/biologic + device products to market.

Pharma's Device Team for Combination Products

We help bring drug/biologic + device products to market.

Suttons Creek partners with pharmaceutical companies, providing services including expert consulting, embedded execution, training and guidance for the development of combination products. Our services create success in global regulatory affairs, quality systems, device engineering, commercial launch and digital support platforms throughout the entire product lifecycle.

We can customize our services to meet your immediate needs, your short-term initiatives, or your long-term strategic goals. For those clients who require smaller steps, we offer on-call, hourly consulting contracts to guide and execute as needed and as budgets allow.

PharmaEd Steve Badelt and Carolyn Dorgan

Our 2023 Industry Event Schedule

Our team is ready to get out there to teach, learn, and connect with our industry colleagues. We have set a schedule of events to attend and are solidifying opportunities for our experts to share combination product knowledge with you. Check back for updates throughout the year.

If you are a trade event organizer and have an interest in any of our experts speaking at your event, please email us. If you are interested in meeting with our team members at an industry event, you can also always complete our contact form, call us, or click the button below to connect.

PharmaEd Steve Badelt and Carolyn Dorgan


SCI’S Technical Directors, Carolyn Dorgan and Jonathan Amaya-Hodges are sharing their knowledge at AFDO/RAPS’s CP Summit in Forth Worth, TX on November 28th through the 30th, Jonathan talking about “Use Of Non-Integral Medical Devices In Medicinal Product Clinical Studies” (11/29) and Carolyn discussing “Building Clarity To Address Regulatory Challenges Of On-Body Delivery” (11/30). Our CEO/Founder, Steve Badelt, PhD, and President/COO, Rob Schulz, will be joining them at the event, all ready to offer our industry colleagues free insight sessions to help you find your best combination product strategies. Please reach out if you are interested in setting up a meeting.

PharmaEd Steve Badelt and Carolyn Dorgan


Sutton Creek’s CEO/Founder, Steve Badelt, PhD, will be heading back to La Jolla, CA to chair PharmaEd Resources’ Pre-Filled Syringes and Autoinjectors Forum. Principal Consultant and combination product expert, Kelly Wedig, will also be there, speaking at the forum on “A Technique for Integrating Risk Management Processes for Combination Product Development.” We invite you to join them, and our Director of Sales, Craig Voellmicke, to learn about the newest innovations and development best practices in pre-filled syringes and autoinjectors. If you would like the opportunity to pick one of our experts’ brains at the show, please click below to set up a meeting!

The complexities of combination product development and regulatory approval are ever-changing.

Advancements in science, technology and patient-care require continuous adjustments by the FDA, the EU MDA and other global regulatory agencies. This is why it is important to have a team of experts who are well- versed in current standards, practices and regulations on your team.

When a pharmaceutical company is working to bring a new, life-changing combination product to patients, Suttons Creek and its device and digital support platform specialists bridge the gap between pharma’s drug expertise and the highly specific, varying and intricate world of combination product regulations.

Our vantage point of experience gives our clients peace of mind, knowing that they are making decisions based on proven success.


Our team of medical device experts provides support through your entire product life cycle, from project inception to commercialization and post-launch activities. We integrate into your team and execute from day one but can also jump in at any stage in crisis.

Click to see our Services.


We have a combined 650+ years of medical device and combination product experience, and we have worked on over 120 products, encompassing a wide variety of drug delivery systems and supporting digital software, for over 70 pharma clients. Our specialists have the experience to have “seen it before” and the know-how to navigate around all of the potential pitfalls of the process. Auto Injectors, Pre-Filled Syringes, On-Body Devices, Software as a Medical Device (SaMD) and more, we can help you develop it.

Click to meet our Device Team.


We have an established track record for reducing execution risk and development timelines for our clients, while increasing efficiencies and product consistency, quality, reliability, and robustness. From these successful ventures, we have created proprietary systems to set your combination product up for a quick and painless global regulatory process. Whatever medical device you’re working on, there’s a great chance we’ve helped a pharmaceutical company like yours succeed in that space.


Click to see Client Testimonials.


Our consultants are specialists who work as an extension of your team to first identify what your drug delivery system, software, or quality needs are, and then tailor our approach to ensure your desired outcomes and timelines are met. We work with an adaptive, agile and customized systems approach that solves your specific problems without impeding on your existing medicine and molecule processes already in place.


Click to read about our Approach.

“…Thank you for all of the critical support provided over the past few weeks and jumping in with a 110% commitment to helping us navigate this fire drill at all hours of the day! …getting a high quality 483 response document out today was a huge milestone and your contribution to this was vital.”

—Senior Vice President, 
Big Pharma

Let Suttons Creek drive the integration and regulatory pathway of your combination products, so you can focus on delivering life-changing drugs.

What Suttons Creek Combination Product Consultants Can Do For You.

At Suttons Creek, we don’t expect you to be an expert in the combination product space. Your area of mastery is in pharmaceutical development lifecycle and patient impact. Ours is drug delivery devices and supporting software platforms. Our team can create and deploy a device strategy that will lead your combination products to success.