SERVICES
Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies whose activities are regulated by the Food and Drug Administration (FDA) and works on behalf of companies developing innovative solutions to pressing public health challenges around the globe.
Greenleaf provides regulatory guidance to leading pharmaceutical, biotechnology, medical device companies and tobacco on issues that include, but are not limited to:
Product Lifecycle Management
- Strategic guidance regarding the FDA regulatory process
- Product pricing
- Coverage and Reimbursement
- Post-market safety requirements
- Generic competition
Product Approval
- Complete Response Letters
- FDA Advisory Committee meetings
- Personalized medicine and the FDA approval process
Product Labeling
- Strategic guidance on new labeling requirements
- Risk management plans (Risk MAPs)
- Risk Evaluation and Mitigation Strategy (REMS) safety plans
Manufacturing and Compliance
- FDA inspection process
- Assessment of Form 483 and EIRs
- Current Good Manufacturing Process (cGMP) deficiency letters
- Corporate warning letters
Marketing and Promotional Practices
- Direct-to-consumer (DTC) advertising review process
- Remediation of untitled and warning letters
- Use of social media
Regulatory Policy
- Follow-on Biologics
- Generic drug issues
- FDAAA implementation
- FDA policies and processes
- FDA Advisory Committee analysis
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With experience in both the private and public sectors, Greenleaf harnesses its extensive institutional knowledge of FDA and CMS to interpret recent or pending regulatory actions on behalf of its clients.
As a leader in the life sciences area, Greenleaf is privy to key legislative and regulatory information, knowledge that will be increasingly valuable as the FDA continues the process of implementing recent changes to the Federal Food, Drug & Cosmetic Act (FFDCA) and enhances its post-market safety capabilities.
Finally, Greenleaf carefully tracks pending legislation on Capitol Hill that could affect current regulatory and reimbursement schemes and advises clients about the potential impact of such legislation.