Suttons Creek Inc

Integrated subject matter experts guiding strategy and executing deliverables to develop combination products, gain regulatory approval, and achieve successful launches.

• Quality Systems

  Establishing compliant Quality Management Systems (QMS) and Part 4-compliant processes for combination products.

• Device and Vendor Selection

  Assisting clients in selecting and managing drug delivery systems, device platforms, and external suppliers.

• Clinical Combination Product Development

  Supporting drug-device development activities from early clinical phases through pivotal trials.

• Commercial Combination Product Development

  Guiding commercialization processes, design transfer, and scaling for market launch.

• Regulatory Preparedness

  Developing premarket regulatory strategies, preparing submission documents, and managing regulatory agency interactions.

• Commercial Launch and Postmarket Activity

  Providing launch execution support, supplier coordination, and ongoing postmarket surveillance.

• Remediation and Readiness Improvement

  Addressing audit findings, responding to FDA 483 letters, and performing gap assessments.

• Audit Preparation

  Preparing clients and suppliers for regulatory audits and vendor readiness evaluations.

• Regulatory Support

  Providing active regulatory consulting and submission coordination throughout the development lifecycle.

• Postmarket Surveillance

  Managing compliance, complaints, and surveillance activities after combination product commercialization.

Support services designed to help executive leadership and management build a robust combination product ecosystem covering culture, alignment, and systems.

• Combination Product Strategy

  Developing corporate-level strategies and strategic options for drug-device integration.

• Executive CP Coaching

  Providing specialized coaching and guidance for executive leaders navigating the medtech and combination product sectors.

• Organizational Development

  Building internal capabilities, alignment, and cross-functional structures to support combination product programs.

• Education and Training

  Delivering educational programs on combination product device topics, quality systems, and regulatory requirements.

• Corporate Readiness and Change

  Guiding organizations through the operational and cultural changes needed to adopt combination product workflows.

• Turn-key Strategy

  Formulating complete, end-to-end strategic roadmaps for manufacturers, service providers, and pharma companies.

• Combination Product Startup

  Helping clients establish their very first drug-device combination product programs, assessing options and building phase-appropriate plans.

• Combination Product Readiness

  Assessing organizational readiness and establishing the core systems needed to support advanced stage development.