FDASmart Inc. FDA Registration | U.S. Agent | FDA Regulatory Assistance for Food, Medical Device

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Overview

Overview Building better FDA submissions--

Mission Statement Training Experience

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

	Adverse Event Reporting
	Two of Training Classes
	Class Title	Description
1	A Survey of Adverse Event Reporting Requirements for Drugs and Biologics	A summary of FDA’s regulations about AE reporting for drugs and biologics. Advice on how to improve reporting processes. INCLUDES 8 MODEL SOPs..
2	A Survey of Medical Device Adverse Event Reporting Requirements	A summary of FDA’s regulations about medical device AE reporting. How to improve reporting compliance. INCLUDES 9 MODEL SOPs.