Suttons Creek is Your Full-Service Combination Product Device Team
Bridging the gap between pharma and devicesOffering a wider scope of benefits as a proud member of the BlueRidge Life Sciences family of companies.
Bring competitive combination products to market on time and on budget.
You’ve developed combination product(s) in the past and have a dedicated in-house device team to work with your CMC teams and suppliers. Despite this, significant challenges are still likely to arise due to fast evolving device delivery technology, regulatory landscape, and processes needed to bring competitive combination products to market on-time and on-budget.
In Suttons Creek’s experience working in-house for Big Pharma and supporting as consultants, we have seen even the biggest global drug companies stumble with getting combination products approved the first time around, struggle with resource issues, uncover knowledge and experience gaps (for novel product types or managing evolving regulations), and have difficulty aligning the cross-functional teams and external parties that need to work seamlessly together to bring products to market.
On these projects, the integration of Suttons Creek subject matter experts has resolved issues, shortened timelines, reduced budgets, and supported the approval and launch of over 80 drug and biologic delivery devices.
Our team offers Corporate Development to empower and enable your CP program on top of expert Program Execution that will guide you through the key stages of successful combination product development, regulatory approval, and launch.
COMMON PHARMA SERVICE PACKAGES
SCI packages that are generally engaged by Pharma companies across their combination product development lifecycle. A full list of our services can be found here.
Strategy + Corporate Readiness
The best time to bring in combination product experts is at the beginning, when you are setting strategies, forecasting, and gathering your resources. Even before “the work” begins, you can start saving time and money by creating strategies that incorporate current best practices and align your drug and device systems. Our experts assess your current program structure and provide feedback and guidance on combination product development, regulatory, and commercialization strategies, as well as guidance on compliance QMS (21 CFR 4). Common deliverables include:
Combination Product Development
The device constituent (and vendor) you select is critical to the success of your product. Our experts have worked on, and some have even regulated from within the FDA, most drug delivery device types in the market, and we have experience working with the industry’s top vendors , emerging technologies, and innovative companies. With your desired timeline, technical and program needs, and supplier global risk management goals in mind, we help determine key metrics to select the partner(s) who will best meet your needs in current and future lifecycle steps.
We also provide modular cross-functional combination product development support throughout the product lifecycle. Customized to your unique situation, we plug in experienced subject matter experts (including development engineers, quality engineers, regulatory experts, human factors specialists, and program managers) where needed to support your internal team. Common deliverables include:
Combination Product Commercialization
Our team supports Pharma and their vendors in transition from clinical testing to commercial device readiness and through regulatory filing. As scale up and regulatory approval is in the works, our commercial experts step in to prepare your team for commercial launch and postmarket responsibilities. Common deliverables include:
Remediation + Readiness Improvement
EXPEDITED ROADBLOCK RESOLUTION
We have the agility and flexibility to step in quickly, even later in the game or when big problems need fast fixing. During any phase we can jump in to get your program audited, on track, and executed in the most timely and cost-effective way possible. Common deliverables include:
- Project Gap Analysis
- Product Audit
- Process Audit
- QMS Audit
- Regulatory Audit
- Program Pressure Test / Gap Analysis (All of the above deliverables)
- Regulatory Remediation Support
- Design History File (DHF) & Process Audits
- Retrospective Development Support
- Retrospective/Remediation Strategy Consult
- Medical Device Regulation (MDR) Preparation/Strategy
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.
Not quite ready to reach out? Get in the combination product expert loop by connecting with us by following our LinkedIn company page or subscribing to receive our industry news emails.
You can also find case studies and testimonials from your industry colleagues’ projects…