Our Approach to Combination ProductsCreating a pathway to FDA and global approval
Knowledge & Understanding
Your forward progress and success with combination product programs requires knowledgeable leaders and managers for guidance and support in this ever-changing technological and regulatory landscape. They need to understand their options, and they need to know what factors can affect your success.
We have assembled an expert team of consultants with more than 650+ years of combined pharmaceutical, device and software experience. After working on over 60 approved drug delivery systems, our combination product experts will help your leaders and managers effectively understand and navigate the regulated development process.
We work with pharmaceutical companies of all sizes to support the delivery of health-improving combination products through cultural integration and education programs, pinpointing relevant Quality Management Systems (QMS) and regulatory compliance for regulatory approval, and determining the most effective and efficient execution of desired products for clinicians and patients.
Without knowledge and understanding, it is impossible to deploy optimized systems for quality compliance. So, every step of our involvement is guided by informed choices and ensuring our client’s full team is not only effectively knowledgeable in their own activities, but informed and invested in the entire process.
Adaptive & Customized
We build combination product systems to work with and within your existing systems.
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. We take the time to not only answer those questions and custom-design an engagement model that suits your specific needs the best, but we also study your existing systems to determine the least intrusive way to adapt our processes.
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. Our adaptive approach allows us to be the architects of customized documentation so you can improve your systematic processes – not redesign them – and get the job completed in a compliant and efficient manner.
Full-Service, Cradle Through Life Cycle
At Suttons Creek, we pride ourselves on our ability to collaborate with pharmaceutical companies and to get you across the regulatory finish line faster. We use our knowledge and expertise to do it right the first time and to cut out the “grey area” unnecessary work that takes up time and resources and can ultimately add risk to your process.
From regulatory submissions to standards analysis, from MAAs to RTQs, from essential design outputs to discussions with CDRH and CBER—we offer services that support and educate you from your initial contact with regulatory agencies and execute on your behalf through the final submission.
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 life cycle 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.
Though, we do suggest starting the conversation at inception – even if this is just for the purpose of determining where in your life cycle you will require expert engagement. Otherwise, you could miss critical steps, or make missteps, that can cause your combination product program to get stalled or stymied. While we do offer Remediation services to help pharma companies in crisis, we can all agree that taking steps to avoid that headache and potentially wasted time and resources is a better option.
There are many variations that are specific to each pharmaceutical company’s combination product portfolio, goals, internal resources and existing systems. These nuances result in unique and specific needs. The expertise, experience and knowledge-base of the device team that executes each program needs to be precisely suited to fit those needs.
For each client project, Suttons Creek assigns a team leader with the core competencies to oversee the execution of your combination product presentation. Your team leader then hand-picks a unit of specialized consultants, assembled to assist with your project’s unique requirements. Whether it be Human Factors & Usability Engineering (HFE/UE) activities like design validation and formative/summative testing; or, identifying potential partner vendors to support your Software as a Medical Device (SaMD); or, navigating the new European Union Medical Device Regulations (MDR) – we have experts that will lead you to success.
Our team is your team, and with over 230 years of combined drug, medical device and SaMD experience, we have a consultant team that can take you across the finish line.
Here’s what our clients are saying…
“Suttons Creek strikes the right balance between attention to detail and a systems- level approach.”
“We recognize the value that Suttons Creek has brought to our team. I frankly do not know how we could have achieved our goal without their help.”
“You guys are the organization that is REALLY helping Pharma companies bridge the gap.”
“SCI’s support has been integral in expanding our knowledge into the device space, as well as supporting us when we need on-site training.”
“We would not have gotten this project out on schedule without the leadership of Suttons Creek”
“Is this the point at which you should tell us, “we told you so”?”…
“Thank you for all of the critical support you’ve both 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! I know there’s still a lot of work ahead, but getting a high quality 483 response document out today was a huge milestone and your contribution to this was vital.”
“Yes, [SCI has] added a lot of value and has also been very flexible as our business priorities shifted over time, which we appreciate very much!”
“Thank you and the team for the attention, diligence, focus and understanding of our crazy timeline!“