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

Join us at key combination product events this year…

Our team will be heading to the below events and hope to see you while we are there. If you are interested in meeting with our team members, you can also always complete our contact form, call us, or click the button below to connect.

If you are a trade event organizer and have an interest in any of our experts speaking at your event, please email us

PharmaEd Steve Badelt and Carolyn Dorgan


Join Rob Schulz, RAC along with fellow panelists Andrea Gray, PhD (FDA), William Daunch, PhD (Focal Medical, Inc), and Michael Lehmicke, MSc (Regenerative Medicine) in San Diego for the DIA (60th anniversary) Global Annual Meeting. Chaired by James Wabby, MHS (Abbvie), this group of FDA and industry leaders will discuss advanced drug delivery technologies and cell/gene therapies in combination products. The group plans to illustrate hot topics and provide example case studies in a panel discussion that will help us navigate the future regulatory framework for unmet medical needs and next generation of medical products.

Rob will also be supporting a roundtable discussion for a deeper dive “Solutions Room” session on regulatory issues surrounding delivery technologies for cell/gene therapies. It is an opportunity for leaders and experts at this event to foster dialogue, drive transformative change, and work collaboratively to shape the future of cell and gene therapies. This session in invitation-only: once you have registered for the event, please express your interest in participating through this link.

If you will be there, reach out to connect with Rob!

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.