DRUG & BIOLOGICAL PRODUCTS
The Drug and Biological Products Team delivers a variety of services from the earliest stages of product development through postapproval commitments. Services include monitoring and assessing the regulatory environment for emerging trends, analyzing the impact of agency actions on current development programs, and reviewing the competitive landscape for specific therapeutic areas.
Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, as well as postmarket requirements, including safety monitoring. The team’s approach, firmly grounded in established principles of public health practices, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.
Greenleaf’s Drug & Biological Product Services
Product Lifecycle Management
- Strategic guidance on FDA’s regulatory process
- All aspects of product development
- Premarket review
- Postmarket safety requirements
- Analysis of the market to identify potential competition
Premarket Review Process
- Scientific, medical and regulatory guidance for clinical programs and regulatory filings
- Strategic guidance and preparation for FDA meetings, including advisory committees
- Analysis of, and recommendations on, FDA communications
Marketing & Promotional Practices
- Strategic guidance on labeling requirements
- Promotional materials
- Direct-to-consumer advertising review processes
- Remediation of untitled and warning letters
- Use of social media
Regulatory Policy Guidance
- Analysis of FDA policies and processes
- User fee requirements
- Advisory committee analysis
- Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures
