Drug & Biological Products

In the challenging world of biopharmaceutical development, companies need a trusted regulatory partner to help them make timely, informed decisions. Greenleaf’s respected FDA experts provide a vital perspective to clients on the complex process of bringing new therapeutics to market.

Our Drug & Biological Products Services

Strategic Regulatory Guidance

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

Premarket Review Process

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

Drug Development Tool Services

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.

Given the complexity of DDT use for regulatory decision-making, Greenleaf works to develop a comprehensive, multi-Center engagement strategy to ensure that clients are meeting regulatory expectations of the tool, its measurement, and its data requirements. Whether a client is an experienced pharmaceutical or biotech company or a technology start-up with little regulatory capacity, Greenleaf adapts its support services to provide an integrated regulatory strategy across FDA product Centers and engagement pathways.

  • Critical assessment of a client’s DDT proposal, prioritization of responses to likely regulatory challenges, and potential approaches to aligning with the FDA on DDT development strategy
  • Review of a client’s landscape analysis to assess the drug development need for a therapeutic area and how a DDT may address that need
  • Defining attainable milestones as part of a long-term development strategy to support FDA acceptance of a DDT’s ultimate and desired use
  • Determining the evidence needed to support a DDT’s use, including enrichment strategies and use as endpoints, including surrogates
  • Assessment of regulatory precedents and guidance on leveraging case studies to inform desired regulatory outcomes
  • Strategic analysis of a tool’s measurement, validation, and interpretation within the context of a drug clinical trial
  • Advice on best practices for data collection procedures to ensure that a tool’s information will meet the FDA’s expectation for GCP guidelines
  • Training opportunities for a client’s staff and management
  • Advice on establishing effective partnerships within the medical product development enterprise

Combination Product Support Services

Greenleaf provides strategic advice throughout the combination product lifecycle, including all potential premarket pathways (NDA, ANDA, BLA, PMA, 510(k), De Novo). Our experts have extensive experience with drug-coated devices and a wide range of drug delivery systems including subcutaneous, inhaled, injected, topical, intrathecal, and closed loop. We also have knowledge and experience with designation and development of companion diagnostics.

Greenleaf has expertise to help sponsors determine the regulatory identity (classification) of their product as a drug, device, biological product, or combination product. For drugs and biological products, Greenleaf can prepare Requests for Designation (RFDs) and pre-RFDs to determine the regulatory identity and responsible FDA Center.

Learn more about Greenleaf Health’s Combination Product Support services

Pipeline Review 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

Regulatory Policy Services

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

Cell and Gene Therapy

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

Digital Health 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

Advisory 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

Success Stories

  • Restarting a Stalled Development Program

    Greenleaf Health worked with a multinational biopharmaceutical manufacturer to reinitiate their phase 3 program for a women’s health product, which had stalled after the FDA had voiced concerns with the design of the pivotal trial. The client needed a way to fulfill the Agency’s request for additional long-term outcomes data, which would require an expansion …

  • Leading a Client Through Dispute Resolution to Product Approval

    Upon receiving a Complete Response Letter (CRL) for their lead product to manage mild to moderate pain, a mid-sized specialty pharmaceutical company engaged Greenleaf Health to assist them in addressing the deficiencies cited in the CRL and developing a strategy for resubmitting the new drug application (NDA).  Greenleaf’s regulatory experts, in conjunction with a partner …

  • Developing a Regulatory Strategy to Successfully Manage Assessment and Conduct of a Large Phase 3 Program

    Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …

Drug and Biological Product Resources

View or download the PDFs below to learn more about Greenleaf and our drug and biological product capabilities.

Connect With an Expert

Greenleaf’s Drug & Biological Products Team is ready to help you achieve your regulatory goals. Please provide the information below and a team member will be in contact.

Connect with Expert - Drugs