Drug & Biological Products

Greenleaf experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements. Our strategic consultation encompasses:

• FDA regulatory programs and procedures
• Product development
• Endpoint and biomarker selection, development, and regulatory review
• Use of real-world evidence in regulatory submissions
• Product classification and jurisdiction
• Premarket review processes
• Postmarket safety requirements
• Pipeline decisions and optimization

Drawing on deep knowledge cultivated during their careers as FDA leaders and senior officials, Greenleaf’s advisors deliver analysis and guidance on an array of issues companies face throughout the premarket review process, including:

• 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
• Determination of classification as a drug, biological product, or combination product and preparation of Requests for Designation (RFDs) and pre-RFDs to determine regulatory identity and responsible FDA Center
• 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

Greenleaf’s team includes regulatory policy experts with extensive experience providing insight and recommendations to small and large companies, trade associations, patient organizations, and other stakeholders on:

• FDA regulatory policy, including novel programs
• Product designations and access to expedited programs
• Regulatory issues arising both pre and post market
• Regulatory intelligence and scientific policy
• Building client capacity and understanding of regulatory policy issues

Learn more about Greenleaf’s Regulatory Policy services

Our team’s multidisciplinary expertise helps companies evaluating and prioritizing their drug development pipeline to understand and effectively manage regulatory risk. We provide pipeline evaluations, gap analyses, and customized strategies for:

• 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

Greenleaf’s experts provide strategic regulatory support for the development and regulatory use of drug development tools (DDTs), including biomarkers and novel technologies. In addition to critical assessment of a client’s goals, Greenleaf identifies regulatory and/or scientific gaps and recommends potential paths to address those gaps.

Greenleaf supports drug and biologics clients with strategic review and guidance related to:

• Labeling requirements
• Promotional materials
• Direct-to-consumer advertising review processes
• Use of social media
• Remediation of untitled and warning letters

The Drug and Biological Products Team assists sponsors of cell and gene therapies with FDA interactions and submissions — including early INTERACT and pre-IND meetings; requests for orphan drug, RMAT, and rare pediatric disease designations; and data comparability questions — and helps to clarify FDA requirements for specific types of cellular products. The team also provides guidance on how to maximize clinical trial design for cell and gene therapies to treat rare and ultra-rare diseases.  

Learn more about Greenleaf’s Cell and Gene Therapy services

Greenleaf experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of FDA digital health requirements.

Learn more about Greenleaf’s Digital Health Services

Experts from the Drug and Biological Products Team 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 Advisory services