With over 35 years of combined Regulatory, Quality and Clinical services we have been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market.
Application and Submission Services:
- Assistance with Regulatory Strategies and Assessment
- Preparation of FDA Registration and Listing, US Agent for FDA Requirements
- Liaison with FDA for Pre-submission or Special Meetings
- Assistance with FDA's GCP Requirements for Sponsors, Monitors, and Clinical Investigators
- GCP Audits/Monitoring and Data Integrity Audits
- Statistical Reports
- Guidance in Development of Briefing Package for FDA Meeting
- 510(k), IDE, PMA Preparation and/or Assistan...