FDA Consultant Practice Areas
We represent FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, OTC drug, and animal products industries. With a focus on international trade, we advise clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Our firm is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S. Marc Sanchez, President and Senior counsel, frequently provides interviews and contributions to major press outlets, including the Washington Post and Huffington Post. Marc teaches FDA law as an adjucnt professor at Northeastern University and is the author of two textbooks on FDA law.
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If you have received a 483, warning letter, import detention order or need immediate assistance during an FDA inspection, please call 202.765.4491 or e-mail firstname.lastname@example.org
- Warning Letter and 483 Response and Representation;
- Recall Management and Intervention;
- SNAP Trafficking Violations (defense, application for Civil Money Penalties (CMP) etc.);
- GRAS Affirmation for Food Additives and Dietary Supplements/Ingredient;
- New Dietary Ingredients;
- Dietary Supplement Labeling and Claims Counseling (structure/function, health, nutrition etc.);
- Export Certificates (CVM, CBER, CDER, CDRH).
- Product Review and Classification (dietary supplement, OTC drugs, and cosmetics;
- Labeling and Claims Counseling (food, cosmetic);
- Adverse Event and Medical Device Reports;
- Representation with FDA Office of Criminal Investigations (CDER Office of Drug Security Investigations, physician questioning etc.).
- Intervention with FDA and USDA in all matters.
We can assist you with every type of facility registration – drug, food, dietary supplement, and medical device. Let our daily experience reviewing and submitting applications serve you to quickly and effectively enter the U.S. market.
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Natural remedies to everyday vitamins, we offer a broad range of service to the dietary supplement industry. We can review your labels, ingredients, and operations to ensure your compliance with Part 111 and other dietary supplement regulations. Please click the section-header above to learn more.
From farm to fork we can guide you on FDA and USDA regulations. We can assist you with labeling, ingredient approvals, registration and good manufacturing practices. Please click the section -header above to learn more.
Medical device regulations can be dizzying. We can help with Device Classification, Registration, export agreements, and more. Please click the section-header above to learn more.
Starting out in a regulated industry can be tough. We can help. Please click the section-header above to learn more.
From animal feed, to pet treats, and medical devices the FDA covers it all. So do we. Please click the section-header above to learn more.