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Our proven drug delivery / medical device design and engineering expertise allow your ideas to get to market faster with support From Concept to Commercialization

  • Combination Product Development Partners working together as an extension of your Team
  • Resource & Knowledge-Sharing designed to speed you through Product Development & Commercialization
  • Regulatory & Filing Support
  • ISO 13485:2016 and FDA compliant labs and services
  • ISO 17025:2005 accredited test lab

By combining our experience, unique methodology, customized tools and a passion for results we produce tangible results from strategy through launch.

New Product Development

New to Market?
Our innovative and pragmatic approach
reduces time to market and risk


Product Life-Cycle Management

Our focused and responsive support of
marketed products increases productivity


On Demand Solutions for Device Quality, Regulatory, Project Management, Verification & Validation

  • Regulatory Strategy and Development
  • Technical Design and Development
  • Product Risk Management

  • Human Factors Engineering
  • Device Technology Development
  • Operational Readiness

Our Network, Resources, and Facilities support development at any stage in the combination product life-cycle

  • Regulatory Submission Strategy
  • Combination Product Development
  • Risk Assessment
  • Human Factors Engineering
  • Project Management
  • Production Retains & Complaint Handling
  • Small Batch Filling & Device Assembly
  • Test Method Development
  • Test Method Validation
  • Device Technology Strategy Development

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