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Capabilities

R&D and Prototyping

R&D and Prototyping

R&D and Prototyping

  • Prototype Development
  • Chemical Characterization
  • Moiety Interactions
  • Drug Delivery Studies

Preclinical Testing

R&D and Prototyping

R&D and Prototyping

  • Benchtop and In Vitro Testing
  • Biocompatibility
  • Pathology
  • Rabbit, Pig and Ovine Studies

Manufacturing

R&D and Prototyping

Clinical Studies

  • Polymer Synthesis
  • Extrusion
  • Injection Molding
  • Formulation

Clinical Studies

Quality Management

Clinical Studies

  • Clinical Protocol Development
  • Case Report Form Development
  • IRB Submission
  • Site Selection and Qualification
  • CRO Selection

Regulatory

Quality Management

Quality Management

  • Regulatory Opinions
  • 510(k) Submission Preparation
  • PMA Submission Preparations
  • Pre-Submission Support
  • Audit and Investigation Support

Quality Management

Quality Management

Quality Management

  • Startup-Friendly QMS Implementation
  • Quality Audits
  • Fractional Quality Support

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