Profile

Professional summary

18 years of successful Regulatory Consulting and operating a Clinical Research Organization. Hundreds of therapeutic and diagnostic products have been brought to market with our help.

We have substantial experience with regulators in multiple disciplines and generally good relationships with them. We work with virtually all branches and divisions of the US FDA.

In Clinical Research we have ongoing trials at 11 institutions and support numerous others with clients

Engagement overview

18 years of successful Regulatory Consulting and operating a Clinical Research Organization. Hundreds of therapeutic and diagnostic products have been brought to market with our help.

We have substantial experience with regulators in multiple disciplines and generally good relationships with them. We work with virtually all branches and divisions of the US FDA.

In Clinical Research we have ongoing trials at 11 institutions and support numerous others with clients research and clinical teams.

Specialties: Regulatory Strategy, Regulatory Submissions, Regulatory approvals, Clinical Development, Clinical Programs, Clinical Protocol Development, Global Regulatory Strategy and submissions, Pre-Clinical Research- for Medical Device, Pharmaceutical and Biologics businesses from start-up to Experienced organizations

Clients

• Instrumentation Laboratories
• Biokit SA
• BTG International
• Capsovision
• Cambridge Heart
• Orthogem
• St.