DRUG & BIOLOGICAL PRODUCTS
Greenleaf’s Drug and Biological Products Team guides clients through the complete product lifecycle, from the earliest stages of product development, through the FDA submission and review process, to postapproval commitments and quality systems. The team monitors and analyzes the regulatory environment for emerging trends, agency actions that could potentially impact current development programs, and changes to the competitive landscape for specific therapeutic areas.
Greenleaf experts specialize in clinical trial design, FDA submissions, the FDA review program, and postmarket requirements. The team’s approach, firmly grounded in established principles of public health, 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 consultation on:
- FDA regulatory programs and procedures
- Product development
- Premarket review
- Postmarket safety requirements
- Market analysis for potential competition
Premarket Review Process
Effective guidance on:
- Scientific and regulatory practices for clinical programs and regulatory submissions
- Preparation for FDA meetings, including advisory committees
- FDA communications, including formal, in-person, and regulatory correspondence
Marketing & Promotional Practices
Skilled support on:
- Labeling requirements
- Promotional materials
- Direct-to-consumer advertising review processes
- Remediation of untitled and warning letters
- Use of social media
Regulatory Policy Guidance
Specialized insight on:
- FDA policies and procedures
- User fee requirements
- Advisory committee decisions and meeting preparation
- Implementation of new FDA legislation, regulations, guidance documents, and FDA standard operating procedures
