Amaru counsels domestic and global companies in matters involving products regulated by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and relevant state agencies. As a former in-house counsel for a publicly traded company, Amaru is well-positioned to help clients navigate complex legal, regulatory, and business issues.
- Prepared and submitted the New Drug Application (NDA) for a publicly traded global pharmaceutical company and assisted with ongoing communications with the FDA regarding the same.
- Served on the Medical Legal Review committee for a global pharmaceutical company.
- Advises clients on FDA requirements for expedited development and review programs such as fast track, breakthrough therapy, and priority review designations, as well as accelerated approval.
- Represents and guides clients in responding to FDA information requests as well as enforcement actions such as Warning Letters, Untitled Letters, Complete Response Letters, recalls, import detentions, and alerts.
- Counsels clients on regulations and policies involving product lifecycle, beginning with product formulation, manufacturing facilities, supply chain, labeling, compliance claims, regulatory marketing strategy, and advertising.
- Assists companies with due diligence involving the sale and acquisition of companies that produce FDA-regulated products, including human and animal food, as well as pharmaceutical drug companies.
- Assists food companies and trade associations in maintaining an active role in the development of domestic and global governmental regulations, policies, and industry guidance by preparing food/food ingredient related filings, organizing agency meetings, and drafting/submitting comments in response to regulatory actions.
- Experience with emerging food categories such as alternative proteins using plant, microbial, and animal cell-based technologies (also known as cultivated meat), as well as organic products and bioengineered ingredients.
- Assists clients with novel issues posed by the COVID-19 pandemic.
- Executive Director, Legal/Regulatory/Compliance, CorMedix Inc. (2019-2021)
- Associate, Private law practice (2017-2019)
- Project Manager, National Quality Forum (NQF) (2011-2015)
- Health Policy Research Analyst/Advisor, Massachusetts State Legislature (2009-2011)
J.D., Columbus School of Law, The Catholic University of America
M.P.H., Boston University School of Public Health
B.S., University of Florida
Bar and Court Memberships
- District of Columbia Bar
Related News & Insights
- EventUSDA Animal Production, Raising & Grading ClaimsPrime Label Consultants: 2022 Food Label ConferenceApril 26, 2022
- EventFood Safety – Regulatory and Technological TrendsFood and Drug Law Institute (FDLI) Law Over LunchApril 21, 2022
- EventAlternative Proteins and Regulating Novel ProductsFDLI Food and Dietary Supplement Safety and Regulation ConferenceMarch 31, 2022
- ArticleFood And Beverage Policy Trends To Track This YearLaw360Bob Hibbert, Amaru J. SánchezJanuary 3, 2022