Amaru Sanchez
Counsel
Areas of Focus
- Food & Drug Law
- Health Care Regulatory Compliance Counseling
- Health Policy & Legislation
- Health Care Litigation & Investigations
- Health Care & Life Sciences
- Regulatory
- Focuses on regulatory and policy matters for food, beverage and agricultural products regulated by the FDA, USDA and other regulatory agencies.
- Advises both emerging startups and established global companies in the food, beverage and agricultural sectors.
- Provides regulatory due diligence for business transactions and offers post-closing compliance guidance to ensure seamless and uninterrupted operations.
Amaru has nearly a decade of experience advising food, beverage, life science companies, and investors on complex compliance, regulatory and policy issues. Amaru has deep expertise in U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) food safety frameworks. Prior to joining Akin, Amaru served as a senior associate at a global law firm, focusing on pre- and post-market product regulations and in-house compliance strategies. He also has experience in providing regulatory due diligence for corporate transactions and supported clients in developing consumer-facing marketing and product claims.
Amaru also brings valuable in-house experience from his tenure as Executive Director of Legal, Regulatory, and Compliance at a global pharmaceutical company. In that role, he oversaw regulatory filings, including the New Drug Application (NDA) for the company’s lead product, and managed vendor relationships and contract manufacturing operations. Amaru also brings government experience from his role as Lead Health Policy Research Analyst for the Massachusetts State Legislature’s Joint Committee on Public Health. In that capacity, he directed legislative drafting and spearheaded policy research initiatives.
Amaru received his J.D. from The Catholic University of America Columbus School of Law, holds an M.P.H. from Boston University School of Public Health and a B.S. in integrative biology from the University of Florida.
- Advised companies in 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.
- Advised food and beverage manufacturers on food safety obligations pursuant to FDA’s Food Safety Modernization Act (FSMA), including preparing food safety plans for compliance with hazard analysis and risk-based preventive control requirements.
- Provided due diligence on mergers and acquisitions of food, beverage, and dietary supplement business.
- Advised a client on USDA Food Safety and Inspection Service (FSIS) enforcement actions and investigations, led the development of corrective action plans, and engaged with FSIS compliance officers to mitigate enforcement risk and preserve operational continuity.
- Assisted 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.
- Represented and guided 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.
LanguagesSpanish
Spanish
EducationJ.D., The Catholic University of America Columbus School of Law, 2017
M.P.H., Boston University, 2009
B.S., University of Florida, 2006
J.D., The Catholic University of America Columbus School of Law, 2017
M.P.H., Boston University, 2009
B.S., University of Florida, 2006
Bar AdmissionsDistrict of Columbia
District of Columbia
- Health Policy Research Analyst, Joint Committee on Public Health, Massachusetts State Legislature, 2009-2011.
