Regulatory Services

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, or 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):

View specific areas of need by Regulatory area:

• Regulatory Affairs
• Regulatory Compliance

Regulatory Affairs Programs

Regulatory Affair programs and services cover the gamut of knowledge for all Regulatory submissions. Specialties within this area include the following:

• Submission Strategies (U.S. and International)
• PMA / PMA Supplements / Annual Reports
• 510(k) / Special 510(k)
• deNovo
• IDE / IDE Supplements
• Device Classification
• Clinical Studies
• International Registrations / Notified Body
• Design Dossier / Technical File
• Regulatory Reports (complaint reportability)

Regulatory Compliance

Regulatory Compliance programs and services cover all day-to-day Regulatory activities. Specialties within this area include the following:

• Design History File
• Design Controls / New Product Development
• Postmarket PMA Compliance
• 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
• 601091574
  • Development of all labeling materials including product labeling, Instructions For Use (IFUs), and marketing materials that contain product claims
• Internal Auditing
• Compliance Readiness / Inspection Readiness