• Biologics
  • Pharmaceuticals
  • Devices
  • Biosimilars

You want to Achieve Commercial Success.

We want to Shepherd you through the Process.

Let us navigate you through demanding regulatory challenges and provide the ultimate level of professional support to help you succeed.

Unparalleled Insider Perspective

Let our extensive FDA and Industry Experience give you an edge.

consulting services
support services
specialty groups
World-Renowned Scientists and Physicians

It's hard to find this level of subject-matter expertise under one roof.

Full Scope of Regulatory Needs

Our team brings a depth of knowledge and breadth of experience across product types and development pathways.

Turning Raw Data into Stories that Resonate

We are adept at transforming data from complex trials into a compelling story that highlights patient impact and resonates with the FDA.

Building Worldwide Partnerships for Success

We have built an unprecedented record of achievement, assisting clients all over the globe to address nonclinical, clinical and regulatory compliance challenges.

More Than Just Consultants

The route a new biologic, drug or device takes from concept to commercialization is rarely (if ever) linear - it is riddled with twists and turns, replete with unforeseen complications and added complexities. For even the largest firms, it is a daunting, cost-intensive and risky venture with high stakes: missteps cost companies tens of millions of dollars every year.

Our consultants are here to help you navigate this process and provide you with the best strategy for success.

meet our people

Professionally serviced over 3,500 companies in 53 countries


  • BLAs/NDAs
    (full & supported)
  • 510(k)s
  • IDEs

Let Our Breadth of Experience Guide You

We take pride in delivering innovative solutions and extraordinary results for our clients. The results we achieve are a direct result of the diligence, commitment and breadth of experience that we bring to each client engagement.

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