Regulatory Affairs

Count on our expertise when navigating the regulatory maze

We’ve done regulatory consulting in more than 50 countries

Today’s regulatory landscape is more complex than ever, a daunting maze of requirements and guidelines that never stops evolving. Our regulatory affairs experts have the strategies and tactics to navigate this challenging terrain and more effectively manage your interactions with regulators.

We’ve done regulatory consulting in more than 50 countries and intimately understand the FDA, European agencies, and other regulators around the world. We can help you map the most efficient way to design and conduct your development program and maximize your success across all development phases.

Complete and accurate regulatory submissions are critical, and we have a lot of experience helping customers plan, prepare, and submit them. When the rules change, we’re on top of it, and we can help you deal with emerging regulatory issues and business opportunities that arise during the product life cycle.

Some of our services

  • Regulatory consulting, including:
    • Drugs
    • Biologics
    • Devices
    • 505(b)(2)
    • Drug/Device Combinations
    • IVDs, including Companion Diagnostics
    • Orphan Product Development
    • CMC
    • Nonclinical Safety
    • Healthy Authority Interaction
  • Regulatory operations
  • eCTD/Electronic submissions
  • eTMF / Electronic Trial Master File Management
  • Clinical science & medical writing
  • U.S. authorized representative
  • EU legal representative
  • Regulatory agency liaison
  • Regulatory due diligence

Our experienced team can develop your:

  • Strategic development plans
  • FDA meeting preparation
  • IND preparation and submission
  • Orphan drug, breakthrough, and fast-track applications
  • Study design
  • Clinical study reports
  • Global safety database design
  • SAE reporting

The difference is our people

  • They have established relationships with the FDA, EMA, and the EU competent authorities.
  • Our in-house experts have broad experience working for large and small pharma companies, CROs, and regulatory agencies.
  • All have managed multiple submissions in varied FDA divisions.
  • They’re experienced with CTA submissions in accordance with Europe’s Clinical Trial Directive.

Useful information
Achieving Breakthrough or PRIME Designation
Achieving Breakthrough or PRIME Designation

Phone Us Now
Email Us Now