Safe, Effective, Accepted


Ensure your Product is Safe, Effective, Accepted

Areas of Focus

We allow you to launch products that save lives by helping to ensure that your quality system and marketing campaigns meet all regulatory requirements.

Quality System development

  • Validation
  • Process Controls
  • Corrective Action

Regulatory strategy 

  • Audit Management
  • Product Submission
  • Agency Interaction

Product launch 

  • Marketing Authorization
  • Design Transfer
  • Commercial Strategy

About Us

10+ years in biomedical industry

Biomedical research, clinical diagnostics, drug/device combination products

Strategic and tactical expertise in quality system development, regulatory strategy, and product launch

Experience at leading firms including Becton Dickinson, CR Bard, Beckman Coulter