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

Non-Clinical

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

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

US FDA Agent Services for Foreign Clients

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