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Best Practice Database
Business Operations » Organizational Strategy and Structure
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Behind every successful New Drug Application is an effective relationship involving representatives of the pharmaceutical industry and the U.S. Food and Drug Administration. Across the pharmaceutical industry, both small and large organizations place responsibility for oversight of FDA interactions within Regulatory Affairs.
This study examines what Regulatory Affairs organizational structure works best for interacting with the FDA and how the Regulatory function should lead interactions with the FDA. Additionally, this research explores how some organizations have found success in using a Rockville satellite office as a bridge to building lasting FDA relationships and providing insights on emerging regulatory issues.
Regulatory leaders can use the insights from this research to compare and adjust their group’s structure and how their Regulatory function leads FDA interactions.
If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.