Compliance
Creativity in
Context.
Navigating the gray area.
At Gardner Law, we stand out by bringing colorful problem-solving and risk assessment acumen to the gray area every day. Our attorneys understand how to deliver our clients useful, lawful and practical solutions that can be articulated into actionable steps efficiently. We get to the point quickly. Utilize our experienced team for any step of the process from ideation, R&D, clinical testing, regulatory submission, manufacturing or commercialization. We find creative ways to make whatever needs to happen, happen.
Representative Matters Include:
- Outsourced compliance function
- Designing and implementing compliance programs
- Monitoring and auditing
- Training management teams and staff on compliance laws and regulations
- Analyzing sales and marketing programs for compliance with FDA, CMS, OIG, OCR, FTC requirements
- Assisting companies subject to Corporate Integrity Agreements (CIA)
- Investigating allegations and hotline reports
- Reviewing discounting practices for Discount Safe Harbor compliance
- Analyzing transfers of value to HCPs for compliance with the Personal Services and Management Contracts Safe Harbor
- Reviewing reimbursement support services and program hubs
- Conducting compliance audits and compliance risk assessments of commercial activities
- Helping to mitigate, wind-down, and/or terminate risky practices
- Performing healthcare and FDA regulatory due diligence for buyers and sellers
- Training on best documentation practices
- Reviewing contracts
- Auditing against the PhRMA and AdvaMed Codes
- Transparency (sunshine) reporting to federal, state, municipal authorities