Combination Product device, regulatory, clinical, and manufacturing decisions made in isolation create downstream risk.
Most teams don’t see the problem until after the FDA brings it to their attention.
When device, regulatory, and clinical don’t align, timelines slip.
Missteps can cost you time, money, and marketshare.
Never assume your CMO maintains the necessary documentation for your Design History File. Doing it right the first time means establishing your own right-sized regulatory strategy, combination-product QMS structure, and Design and Development File (DDF). Without that, you will face risk of delays and rework that could jeopardize submission timelines.
For complex combination products, failure isn’t an option.
Intricate documentation structure, technically complicated device constituents, novel combination product types, and evolving regulatory requirements can lead to regulatory issues that have had material effect on the company. When one or more of these situations are present, the safest way through is guided by experts who have done it before.
When you reach out
Our business development team will contact you for an informal discussion to better understand how our team can help and answer any questions you have about what we do and how we work with clients. From there, a complimentary working session with one of our technical experts can be arranged to further delve into your situation (with appropriate confidentiality paperwork in place) and provide insights into best practices and customized solutions to explore.
Suttons Creek’s full product lifecycle approach to services…
PROGRAM EXECUTION
Integrated subject matter experts guiding strategy and executing the deliverables needed to develop your combination product, gain regulatory approval, and successfully launch your product the first time around.
- Quality Systems
- Device/Vendor Selection and Management
- Clinical Combination Product Development
- Commercial Combination Product Development
- Regulatory Preparedness
- Commercial Launch and Postmarket Activities
- Remediation and Readiness Improvement
CORPORATE DEVELOPMENT
Support services that help client executive leadership and management build a prosperous combination product ecosystem (culture, systems, knowledge, goals, alignment).
- Combination Product Strategy
- Executive CP Coaching
- Organizational Development
- Education and Training
- Corporate Readiness and Change
Why the complex programs come to Suttons Creek…
Sponsor-Side Operational Leadership
Strategic operational guidance across complex combination product programs that helps sponsors align teams, vendors, OEMs, and development decisions without adding enterprise bureaucracy.
Cross-Functional Integration
Integration across regulatory, device, HF, OEM, risk, commercialization, and lifecycle management that reduces the gaps between functions and organizations where programs most commonly fail.
Downstream Consequence Awareness
Focus on how early development decisions impact downstream commercialization and lifecycle success that helps sponsors avoid rework, delays, remediation, bridging challenges, and operational bottlenecks.
Independent Strategic Guidance Across the Device Ecosystem
Independent sponsor-side guidance across OEMs, platform providers, connected delivery systems, and partners that helps sponsors navigate increasingly complex device ecosystems with stronger governance, alignment, and commercialization readiness.
A Boutique Experience Backed by the Power of BlueRidge Life Sciences
As a member of the BlueRidge Life Sciences family, we retain our focus on combination product regulatory and development expertise while offering a turnkey opportunity to capitalize on the toxicology, cold chain supply, human factors, epidimiology, HEOR, and pharmaceutical commercialization epertises of our sister companies.