Worldwide Regulatory Consulting Services

Health Policy Associates provides solutions to regulatory challenges from FDA and other worldwide regulatory agencies that confront the healthcare industry. By working constructively with regulatory authorities, we seek solutions for our clients that resolve regulatory and compliance issues.

Our key services include:

  • Regulatory Strategy
    • Identifying device, drug, biologics, or combination product status and the appropriate regulatory classification and pre-market submission pathway in jurisdictions where the product will be marketed
    • Identifying data requirements to support marketing applications, including any clinical data requirements
    • Input and guidance regarding regulatory implications of desired claims and indications, including assessment of anticipated time and cost to approval and market, improving the probability of success
    • Strategic interactions with regulatory authorities to confirm the planned approach and assumptions
  • Submission Preparation and Support
    • Pre-submission / Pre-IDE Meeting involvement and support, comprehensive literature search and analysis
    • Review of package prior to submission to regulatory authorities, assistance addressing agency questions, and interacting with regulatory authorities to resolve issues
    • 510(k) Premarket Notifications
    • Investigational Device Exemption Applications (IDEs)
    • Premarket Approval Applications (PMAs)
    • Biologic License Applications (BLA)
    • Technical Files / Design Dossiers / Clinical Evaluation Reports for CE Mark
    • Canadian License Applications
    • Applications in Australia, India, China, Brazil, Japan and other global markets
  • Regulatory Representation
    • FDA Establishment Registration / Device Listing activities
    • FDA US Agent for Foreign Establishments
    • EU Authorized Representative for CE Marked devices
    • European Medical Device Trial Support
  • Post-Market Advertising, Promotion, and Renewals
    • Guidance and assistance with regulatory review of advertising and promotional materials
    • Renewal applications in markets requiring periodic license renewals, such as China and Brazil