Regulatory Affairs Solutions

xFDA Consultants will complement your organization to provide diverse regulatory solutions, including diverse product profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities.

Regulatory Submissions

xFDA Consultants provide our clients direction through the entire regulatory submission process.

Our consultants were Experts at the FDA and many have industrial experience. They have an excellent background for connecting with the appropriate regulatory authorities and assisting firms to accomplish their regulatory objectives.

xFDA provides the following Regulatory Services:

Medical Devices and IVD Submissions

  • Pre-Market Notification (510(k))
  • Pre-IDE
  • Investigational Device Exemption (IDE)
  • Pre-Market Approval (PMA)

Pharmaceuticals and Biologics Submissions

  • Pre-IND meeting and meeting package
  • Preparing client for FDA meetings
  • Risk assessment
  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • Biological Application License (BLA)
  • Abbreviated New Drug Applications (ANDA)
  • CTD preparation
  • eCTD submission