Regulatory Filings

The Regulatory experts at Neozene can help your organization establish all processes necessary to meet all regulatory requirements. Whether these requirements are for regulatory submissions, licensure, general compliance, and training, our team of experts will efficiently and effectively establish or assist in establishing a regulatory infrastructure that will withstand scrutiny of any regulatory body in the world. Below is a list of the standard Regulatory services that Neozene offers (this list is not all inclusive):

• Submission Strategies:
  • U.S. Submissions
    • PMA / PMA Supplements / Annual Reports
    • 510(k) / Special 510(k)
    • deNovo
    • IDE / IDE Supplements
    • Design History File
    • Device Classification
    • Design Controls
    • Clinical Studies
    • Postmarket PMA Compliance
  • International Submissions
    • International Registrations / Notified Body
    • Design Dossier / Technical File
• Leading the effort for regulatory agency responses:
  • 483 Finding responses and corrective action plans
  • Notified Body nonconformance responses and corrective action plans
  • Warning Letter responses and corrective action plans
  • Consent Decree responses and response requirements
• Labeling & Marketing Development, Review, & Compliance
  • Implementation of Labeling Systems compliant with EN 980 and ISO 15223
  • GUDID Labeling program establishment and processes
  • Development of all labeling materials including product labeling, Instructions For Use (IFUs), and marketing materials that contain product claims

Neozene, as your Regulatory partner can help you answer the following questions:

1. I just received a Warning Letter. What am I required to do now?
2. I was told that my response to my Warning Letter was insufficient. What do I need to do now?
3. Our company has just been issued a Consent Decree? Do I have to close my doors?
4. What does a Consent Decree mean, exactly?
5. How do I best set up my documentation systems to support my Consent Decree?
6. What is the difference between a Warning Letter and a Consent Decree?