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