Experien Group, Veranex’s global regulatory experts, are known for their well-established and strong relationships with the FDA. Combined with submission expertise and a proven track record of successful approvals, we perform discrete tasks or lead comprehensive programs for your regulatory, quality, and medical device regulatory compliance. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions.

Technology Drives Regulatory Requirements

We have achieved tremendous success for our clients in securing global regulatory approvals and clearances for follow-on and breakthrough technologies. We help you determine the regulatory pathway for desired markets, successfully navigate the submission process, commercialize your devices, and maintain post-market surveillance compliance.

US FDA Services

We recognize the criticality of the U.S. market for medical device companies. We facilitate early FDA interactions and lead submission efforts to ensure alignment for efficient, successful program outcomes. Our team works with every division within CDRH as well as the Office of Combination Products, Office of Compliance, and Office of the Director.

Our FDA Services Include:

  • Annual IDE reporting
  • Complaint handling/medical device reporting
  • Compliance
  • De Novo petition
  • Early feasibility study IDE submission
  • External standards and guidances maintenance
  • FDA certificates and permits
  • FDA communication
  • FDA license registration
  • FDA panel meeting
  • FDA regulatory submissions
  • FDA Q-Sub process
    • Agreement meeting
    • Day 100 meeting
    • Determination meeting
    • Informational meeting
    • Pre-submission meeting
    • Study risk determination
    • Submission issue meeting
  • HUD and HDE application
  • IDE application
  • IDE supplement
  • Labeling
  • Letter-to-file
  • PMA submission
  • PMA supplement submission
  • Recall and enforcement action
  • Regulatory release of product
  • Regulatory review of marketing materials
  • Regulatory strategy
  • State of California Food and Drug Branch (FDB) license registration
  • 510(k) submission
    • Abbreviated
    • Special
    • Traditional
  • 513(g) request

Our Services

We comprehend the value of global clinical and commercialization programs for medical devices. We help clients strategize around go-to-market opportunities in multiple geographies and understand the regulatory requirements for each. We work with most every major Notified Body and Competent Authority/international regulatory agency.

Our International Regulatory Services Include:

  • Change notice
  • Clinical evaluation report
  • Compliance support
  • Design dossier
  • External standards
  • Health Canada license support
  • Health Canada submission
  • Individual country submission (e.g., TGA, ANMAT, ANVISA, PMDA)
  • Labeling
  • Letters-to-file
  • Notified Body interface for CE marking
  • Recall support
  • Regulatory release
  • Regulatory review of marketing materials
  • Self-certification
  • State-of- the-art update
  • Technical file
  • Vigilance/incident event reporting