Executives today face a more rigorous and demanding regulatory environment than those that preceded them. My clients appreciate my prior industry experience and how I apply it in my practice. Since I’ve walked in the shoes of my clients, I know what they are going through. I can relate to their business objectives and help them achieve them in a compliant fashion. This is what sets me apart from other lawyers.
– MARK GARDNER, M.B.A., J.D.
- Compliance assessments, investigations and training
- Design and implementation of compliance programs
- Advertising and promotional review
- Business interactions with health care professionals
- Responding to and negotiating with the FDA and DOJ
- Transparency reporting
- Quality and Regulatory assessments
- Product clinical investigation and FDA approval pathways
- Privacy compliance
- Responding to and negotiating with the government