Who We Are?

A company fueled by the passion and expertise of our people

What We Do?

Create value from small start-ups to multi-national corporations, one firm at a time

How that helps you!

Helps effectively guide you through the FDA regulatory process and mitigate key risks



  • Regulatory Risk Mitigation
  • Strategic Planning/Regulatory Strategy
  • Product Development Strategy
  • Quality Assurance/Quality Control
  • US FDA Compliance, Audits, and Submissions
  • Regulatory Due Dilligence
  • Expert Witness
  • Warning Letters
  • On-site training

Deep Experience and Knowledge

Delivering on compliance and regulatory issues with a deep bench of consulting assets.  We have an interdisciplinary team of product experts, engineers, project managers, and subject matter specialists who can bring strategic advisory solutions that benefit the bottom line of your firm.

We provide operational and regulatory insights which help your firm navigate the complex FDA regulatory framework and translate that into meaningful solutions for your company.