DRUG & BIOLOGICAL PRODUCTS
Greenleaf’s Drug and Biological Products Team has a robust blend of regulatory and policy expertise and FDA institutional knowledge. 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 experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements. Greenleaf advises clients on scientific and regulatory practices for clinical programs and regulatory submissions, identification of and eligibility for special designations and expedited review programs, and preparation for FDA milestone meetings.
The team’s multidisciplinary expertise helps companies evaluating and prioritizing their drug development pipeline to understand and effectively manage regulatory risk.
Experts from the Drug and Biological Products Team also provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.
Learn more about Greenleaf’s Drug & Biological Product Services:
Download Drug & Biological Products Info Sheet
Greenleaf’s Drug & Biological Product Services
Unmatched Regulatory Experience
Strategic consultation on:
- FDA regulatory programs and procedures
- Product development
- Endpoint and biomarker selection, development, and regulatory review
- Premarket review
- Postmarket safety requirements
- Pipeline decisions and optimization
Premarket Review Process
Effective guidance on:
- Scientific and regulatory practices for clinical programs and regulatory submissions
- Identification of and eligibility for special designations, such as breakthrough therapy designation, RMAT, fast track, and accelerated approval
- Preparation for FDA milestone meetings, including EOP2, pre-filing, mid-cycle review, and end-of-review meetings
- Advisory committee meetings and decisions
- FDA communications, including formal, in-person, and regulatory correspondence
Pipeline Review Services
Customized strategies for:
- Effectively managing regulatory risk and reducing regulatory uncertainties
- Planning and decision-making related to clinical programs and regulatory approval
- Prioritizing and addressing programmatic needs for individual candidates and across the portfolio, based on systematic gap analysis
- Drug development options, opportunities, and benchmarks
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
- Implementation of new FDA legislation, regulations, guidance documents, and FDA standard operating procedures
