Regulatory
The Human
Factor.
The Human Factor.
At Gardner Law, we prioritize empathy and clear communication in our counsel to FDA-regulated companies. Our firm possesses recognized expertise in navigating complex FDA regulations, guiding clients through potential pitfalls. With specialized experience, we provide exceptional strategic guidance, ensure timely submissions,and negotiate effectively with regulators.
Representative Matters Include:
- Advertising and Promotion Review
- Regulatory Strategy
- FDA Pathway Assessment
- Clinical Trial Agreement Review, Drafting, and Negotiation
- Research Practices and Negotiating with FDA
- FDA Pre-Submission Meetings
- Quality System Policies and Procedures
- Recalls
- Warning Letters, Untitled Letters, Notice of Violation Letters, 483s, Import Holds, Clinical Holds
- Medical Device Submissions (IDE, 510(k), PMA, De Novo, HDE, EUA, OTC)
- Drug and Biologics Submissions (IND, NDA, ANDA, 505(b)(2), BLA, EUA, OTC)
- Food and Dietary Supplement Safety
- Labeling Negotiation with FDA
- CGMP Compliance
- Mock Inspections and Preparation
- OUS Regulatory Support
