Premarket Approval:
Medical Devices

Phoenix^SM understands the importance of getting a product to market as quickly as possible — without regulatory missteps that can cost thousands or millions of dollars in lost sales later on. Toward this end, we offer:

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 Requirements for Sponsors, Monitors, and Clinical Investigators
	Guidance in Development of Briefing Package for FDA Meeting
	510(k), IDE, PMA Preparation and/or Assistance
	Preparation and/or Assistance with Submission Amendments and Supplements as well as Required Reporting Records
	Development of Strategies for Advisory Committee Meetings
	Assistance in CE Mark Submission

Electronic Registration and Listing

	Electronic Facility Registration
	Electronic Product Listing

Good Clinical Practice

	Assistance with FDA's GCP Requirements for Sponsors, Monitors, and Clinical Investigators
	Good Clinical Practice (GCP) Audits/Monitoring, Data Integrity Audits, Due Diligence Audits
	Statistical Reports
	Good Clinical and Human Subject Protection Compliance
	Protocol Development

Non-Clinical

	Non-Clinical Program Assessment, Development and Strategies by Device Class
	Protocol Development/Study Monitoring/GLP Audit
	Report and Summary Preparation

US FDA Agent Services for Foreign Clients

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Please contact us for additional information or to get help now!