Welcome to my showcase of select academic projects from the Master of Science in Regulatory Affairs program at the College of Professional Studies, Northeastern University.
This collection reflects my dedication to learning, problem-solving, and the ability to apply theoretical knowledge to real-world scenarios throughout my academic journey. Note, each assignment was written and formatted according to requirements specified by each professor.
RGA 6203
Analysis of actual and hypothetical impact of Loper Bright reversing Chevron on administrative agency authority including FDA deference
https://drive.google.com/file/d/1gn6vB0-q_9d5HxTX8ckmUktLc92xdAea/view?usp=sharing
RGA 6463
Adaptive trial case study
https://drive.google.com/file/d/1e8OH3uY2V14ROfzy0OfbU9fCPMX6VXaR/view?usp=sharing
Intellectual Property estate case study
https://drive.google.com/file/d/1KoTN5uAsnOVu91QM-urD1xDRttwqQrsO/view?usp=sharing
Vaccine development case study
https://drive.google.com/file/d/14XT3l0MdKpxc6esgWdIKSrHKyLBna7m-/view?usp=sharing
New drug commercialization case study
https://drive.google.com/file/d/1ovWstYIvRjuMabOKb6MheNllYHZX_cLn/view?usp=sharing
Mock biopharmaceutical product commercialization plan
https://drive.google.com/file/d/1epcLmdFR0ETFNtTVzNjMFulWIWoZYmcu/view?usp=sharing
RGA 6002
Regulatory analysis of QMSR Final Rule impact in implementation
https://drive.google.com/file/d/1HJ7GJlWGdX7S9Mv5eQbmnUkSXjiQ6ip1/view?usp=sharing
RGA 6001
Presentation for mock new product development
https://drive.google.com/file/d/1X6JnDHtODjvfEbOOtDqNNy6ZVGTKGfiy/view?usp=sharing
Mock response to real Warning Letter with strict 1-page limit
https://drive.google.com/file/d/1rZ024Yi_QIQxsJ2-MhupHBhbMHu3xlZs/view?usp=sharing
BTC 6210
Analysis of an FDA Warning Letter under Bioresearch Monitoring Program (BIMO) for a product marketed during COVID-19 PHE
https://drive.google.com/file/d/1RbObDXcVKeR58yzrM_6Nd3X9b18h03V7/view?usp=sharing
RGA 6233
Analysis of three FDA Warning Letters related to QSR violations
https://drive.google.com/file/d/1xB4ProHAtcCVyaSY0EZTvYOrKxelMIMX/view?usp=sharing
Project kickoff meeting presentation for mock qualification as a Quality Director
https://drive.google.com/file/d/1H7NDmg9XMC-LmsO5crnzVkANGvs3hUmq/view?usp=sharing
RGA 6461
Critical analysis of a supplied topic in medical device cybersecurity transparency in regulation
https://drive.google.com/file/d/1vNG_VkL8Ruz6i3HejkgBIHvQ8HpeqTbh/view?usp=sharing
The academic projects and related materials provided on this website are the intellectual property of Gina Catalano. These materials are presented for the purpose of showcasing academic achievements. Unauthorized use, reproduction, or distribution of these works, in whole or in part, is prohibited without explicit written permission. All rights to these materials are reserved and protected by copyright law.
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