Nikita Bhojani
Fda & Healthcare Associate @Morgan, Lewis & Bockius LLP
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WORK HISTORY
Fda & Healthcare Associate @Morgan, Lewis & Bockius LLP
Washington, DC, US
Research and analyze legal issues and risks for the product development, marketing, advertising, distribution and safety of foods, drugs and medical devices; counsel clients to ensure compliance with federal and state laws and regulations and self-regulatory entities such as the US FDA, FTC, USDA, NAD and other regulatory bodies • Conduct legal research, review documents, draft due diligence risk analysis and provide case management for contemplated healthcare transactional matters • Assist life sciences clients in the review, revision, and negotiation of various contracts on matters related to licensing technology, data hosting, platform liability, clinical trial agreements and vendor agreements• Lead food client in reviewing advertising and marketing materials (e.g, labeling and websites) considering FDA laws and regulations, NAD competitor challenges and class action considerations; serve as liaison between client and third-party verification program and lead communications with the third-party to obtain certification for client\'s three food products• Conduct document review and legal productions, legal research and create business compliance presentation for national pharmaceutical client facing government investigation
EDUCATION
University of Richmond School of Law
Juris Doctorate (J.D.), Law
University of Virginia
Bachelor of Arts (B.A.) in Political Science
SKILLS
ABOUT NIKITA BHOJANI
Life-sciences attorney with a cross-disciplinary, regulatory practice and experiences in:> Advising life sciences industries including pharmaceutical, medical devices, food and beverage, cosmetics and dietary supplement clients with navigating pre- and post-market regulatory challenges during the products’ lifecycles and ensuring compliance with FDA, FTC, USDA and other federal and state laws and regulations > Assisting with pre-market product development, FDA submissions and post-market matters, such as product recalls and market withdrawals> Supporting corporate teams on due diligence regulatory risk analysis for contemplated M&A healthcare transactions > Assisting clients in drafting, reviewing, and negotiating contracts including clinical trial agreements, licensing, marketing and vendor agreements > Supporting clients facing internal and government investigations such as FDA, FTC, State AG investigations and NAD challenges > Reviewing advertising, promotion and marketing materials (e.g, websites and labeling) for products and services to ensure compliance with regulatory requirements > Developing internal and external compliance policies related to social media, product claims, telemarketing and privacySpecialities: Regulatory Legal Compliance, Marketing, Promotions & Advertising, Product Development & Marketing
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