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Our Services
Top 10 FDA Services
Warning Letters
1. For businesses who recognize the importance of presenting a solid position to FDA after receiving a Warning Letter.
Apply for Licenses and Approvals
2. For businesses who recognize the complexity of obtaining an FDA or TTB approval and seek trusted counsel on their side.
Registration of Companies/Products
3. For help with preparing and submitting the required documentation to FDA and making annual updates.
PMTAs & SE Reports
4. For companies interested in submitting applications for tobacco product approvals, inc. PMTAs and SE Reports.
Actions By State Tobacco Tax
5. For businesses who need help defending actions by the tax authorities or who are concerned about allegations of wrong-doing.
Operational Impact of New/Existing Laws
6. For businesses that wish to assess the operational impact of nre or existing laws and want help to determine necessary steps for compliance with new requirements.
Legal Compliance SOPs & Training
7. For businesses implementing Standard Operating Procedures (SOPs) and training to streamline operational legal compliance.
Responding To Government Inquiries
8. For businesses facing government inquiries who recognize the importance of responding thoroughly, without saying more than necessary.
Obtaining Non-Traditional Outcomes
9. For businesses with unconventional situations, seeking innovative approaches to achieving desired results
Appeals and Disputes Decisions
10. For businesses aiming to challenge government decisions and obtain a different outcome.
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