“It’s a joy to be able to connect with people all over the world and help simplify their experience navigating U.S. regulatory compliance.”
- Washington, DC
- jcalafiore@ofwlaw.com
- 202-518-6327
Food and Drug Administration
Jessica’s expertise in the FDA space encompasses an extensive range of subject matter. Her experience includes:
- Registration and registration renewal of food, drug, and medical device establishments
- Product listing and listing renewal for over-the-counter drugs, active pharmaceutical ingredients, homeopathic drug products, combination drugs and devices, and unfinished drugs
- Product listing of medical devices
- CARES Act annual drug reporting
- Semi-annual human compounding drug reporting
- Reviewing food and dietary supplement product labels for FDA compliance
- FDA Food Export Lists
- Assisting with the release of FDA-detained shipments
- Petitioning FDA for firms’ removal from import alerts resulting in detention without physical examination
United States Department of Agriculture
- Providing USDA permit determinations
- Obtaining USDA VS permits and PPQ permits
- Obtaining AMS heath certificates and sanitary certificates
- Obtaining APHIS export certificates
Other Agencies and Organizations
Jessica assists with matters pertaining to compliance with other governing agencies, such as obtaining CITES permits and export licenses from the U.S. Fish and Wildlife Service (FWS); registration of pet food products with individual states; and obtaining Certificates of Free Sale from state-level governing agencies, as well as apostilles from their respective secretaries of state.
APHIS Compliance
- Animal Health requirements
- Import/Export requirements
Due Diligence Reviews
Criminal Defense
Practice Areas
Past Experience
- Regulatory Administrator with Benjamin L. England & Associates and FDAImports.com, LLC
Credentials
Education
PCQI Certified – September 2021
News & Insights
May 21st, 2018
January 24th, 2018
September 19th, 2017
