We perform discrete tasks or lead comprehensive programs for your regulatory, quality and clinical requirements. 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 compliance.

regulatory affairs

U.S. 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.

regulatory affairs

Our FDA services include:

  • Regulatory strategy
  • FDA communication
  • PMA submission
  • PMA Supplement submission
  • FDA Panel meeting
  • De Novo petition
  • HUD and HDE application
  • FDA Q-Sub process
    • Informational Meeting
    • Pre-Submission Meeting
    • Submission Issue Meeting
    • Agreement Meeting
    • Study Risk Determination
    • Determination Meeting
    • Day 100 Meeting
  • 510(k) submission
    • Traditional
    • Special
    • Abbreviated

  • IDE application
  • IDE supplement
  • Annual IDE reporting
  • Early Feasibility Study IDE Submission
  • 513(g) request
  • Letter-to-File
  • Labeling
  • Regulatory review of marketing materials
  • Regulatory Release of product
  • Compliance
  • Recall and enforcement action
  • Complaint handling/Medical Device Reporting
  • External standards and guidances maintenance
  • FDA certificates and permits
  • FDA license registration
  • State of California Food and Drug Branch (FDB) license registration

OUS 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.

we ring the bell with every fda success

Our international regulatory services include:

  • Notified Body interface for CE Marking
  • Self-certification
  • Design Dossier
  • Technical File
  • Clinical Evaluation Report
  • Change Notice
  • State-of- the-art update
  • Health Canada submission
  • Individual country submission (e.g., TGA, ANMAT, ANVISA, PMDA, etc.)

  • Health Canada license support
  • Letters-to-File
  • Labeling
  • Regulatory review of marketing materials
  • Regulatory Release
  • Compliance support
  • Recall support
  • Vigilance/Incident Event Reporting
  • External standards

We need people who can become a part of the company in order to guide us through commercialization

Client quote