September 25, 2018


Regulatory submissions are central to gaining market approval and every regulatory agency has its own requirements. Creating a regulatory submission that will move through the approval process quickly and efficiently requires much more than compiling and presenting the data. It also requires careful organization and adherence to the content and format requirements set by the regulatory authorities. Additionally, ongoing communication with regulatory authority staff members, as well as presentations at regulatory authority meetings, are critical to success.

Our team prides itself on their ability to create clean and concise regulatory submissions for major agencies worldwide. This includes the Food and Drug Administration (US), European Notified Bodies (EU), the Health Protection Branch (Canada), the Ministry of Health, Labor and Welfare (Japan), and the Therapeutic Goods Administration (Australia).  Effective communication with regulatory officials is also one of our strong points. Our track record is based on longstanding relationships with regulatory bodies such as the FDA, that have been built on trust.

Expertise Provided

  • EU MDR Technical Documentation
  • GSPR Checklists
  • MDD to MDR Gap Analyses
  • Global Registration Guidance and Support
  • Regulatory Submission Capabilities Include:
    • 510(k)
    • pre-IDE/IDE
    • PMA applications
    • de Novo
    • Technical File & Design Dossier for CE marking
  • Product Team Support to Ensure Devices Meet Regulatory and Product Safety Standards
  • Regulatory Strategy
  • Standard and Guideline Reviews and Guidance
  • Establishment Registration and Device Listing
  • Product Development Protocols (PDP)
  • Post-market Surveillance Protocols
  • Labeling/Labeling Review
  • FDA and other Regulatory Authority Meetings


  • Product support from concept through post-market activities
  • Ability to leverage industry best practices
  • Minimize potential product approval delays
  • Reduced likelihood of audit deficiencies or product recalls