Greenleaf Health consults on strategic regulatory matters for a select group of healthcare sector clients, including pharmaceutical, biotechnology and medical device companies that develop innovative solutions to pressing public health challenges around the globe.
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Greenleaf provides regulatory guidance on issues that include, but are not limited to:
Product Lifecycle Management
- Strategic guidance regarding the FDA review process
- Post-market safety requirements
- Assessing generic competition
- Strategic guidance on new labeling requirements
- Strategic guidance on labeling negotiations
- Risk Evaluation and Mitigation Strategy (REMS) safety plans
Marketing and Promotional Practices
- Direct-to-consumer (DTC) advertising review process
- Remediation of untitled and warning letters
- Use of social media
- Implementation of FDA’s Biosimilars program
- Generic drug user fee requirements
- FDASIA implementation
- FDA policies and processes
- FDA Advisory Committee analysis
Manufacturing and Compliance
- FDA inspection process
- Assessment of Form 483 and EIRs
- Current Good Manufacturing Practices (cGMPs) deficiency letters
- Corporate warning letters
Learn more about the Greenleaf Enforcement Team and Services.
Read about Greenleaf’s 2013 Enforcement Report here.