Advisory Services

Life sciences transactions involve a key component not found in other commercial transactions — the product or company of interest is regulated by the FDA, and regulatory issues therefore must be carefully considered. Greenleaf applies vast FDA institutional knowledge to equip investors with the thorough and focused due diligence needed to ensure that decisions and transactions reflect regulatory risk.

Advisory Services Team

Greenleaf’s team of advisors offers a rare blend of perspectives developed as leaders in both the private and public sectors. Our experience enables us to deliver valuable insight on the broad life sciences industry and the FDA’s current thinking in multiple areas, throughout the product lifecycle.

Our Advisory Services

Regulatory Risk Assessments

The firm’s multidisciplinary team uses its deep regulatory expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry landscape. Greenleaf’s comprehensive due diligence services evaluate a company’s pipeline, or a specific asset, in the following areas:

Analysis of the target company’s regulatory filings and product development plans, including approvals and clearances, special designations, advisory committee decisions, labeling review, and investigational products

Other areas of research and analysis might include:

FDA interactions during the review process
Pre- and postmarket safety reporting
Postmarket study requirements
Competitive landscape

Assessment of the target company’s manufacturing practices, compliance with quality system regulations (QSRs), good manufacturing practices (GMPs), and identification of inconsistencies that may affect the regulatory risk of a product or the company

Other areas of research and analysis might include:

Preclinical and clinical quality systems
Distribution and supply chain
Compliance with pre- and postmarket reporting requirements
Marketing and promotion

Evaluation of the target company’s compliance with FDA regulations and identification of issues that may require attention and resources for remediation

Regulatory Landscape Series

Our Regulatory Landscape Series offers insights from Greenleaf professionals on emerging regulatory matters.

Analyzes the recent activity within the Center for Devices and Radiological Health (CDRH) to address the volume and diversity of Emergency Use Authorization (EUA) requests that have emerged in the in vitro diagnostic (IVD) space as a result of the COVID-19 pandemic

Read the Landscape

Examines the FDA’s approach to inspectional activities during the COVID-19 pandemic

Read the Landscape

Discusses the ways in which COVID-19 has accelerated the use of digital health tools in medical product development

Read the Landscape

Addresses actions to increase domestic manufacturing capacity and modernize medical product manufacturing, both of which are bolstered by pandemic-related legislation and executive orders

Read the Landscape

A timely synopsis of negotiations for reauthorization of the most current FDA human medical product user fees. Greenleaf experts provide an overview of the PDUFA, BsUFA and MDUFA reauthorization process and analyze the current negotiations as they relate to key commitments between the FDA and industry.

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Update on the Drug Supply Chain Security Act (DSCSA), as FDA begins the seventh year of implementation. Greenleaf experts provide an overview of the DSCSA and explore the key components needed to achieve the goal of implementing a fully interoperable and electronic system for securing and tracing products by November 2023.

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Update on the new FDA performance goals related to the increasing use of digital health technologies in clinical care and research. Greenleaf experts address new digital health-related user fee commitments for the medical device and prescription drug programs.

Read the L andscape

The latest installment is a timely update on the the challenging regulation of cannabis products. Greenleaf experts address the continued growth of the CBD industry and the impact of statutory barriers maintained by the FDA.

Read the Landscape

Future Landscapes

Stay tuned for future installments in the Regulatory Landscape Series. To join Greenleaf’s advisory services e-newsletter, please contact Brian Corrigan at Brian.Corrigan@greenleafhealth.com or provide your contact information via the below form:

Regulatory Landscape Series

Register to receive future e-communications from Greenleaf's Regulatory Landscape Series.

Success Stories

Conducting Due Diligence to Guide a Corporate Acquisition Decision

Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …

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Advisory Services Resources

View or download the PDFs below to learn more about Greenleaf’s advisory services and our comprehensive regulatory consulting capabilities.

Advisory Services: Capabilities
Advisory Services: Info Sheet

Connect With an Expert

Greenleaf’s Advisory Services Team is ready to help make your next transaction a success. Please provide the information below and a team member will be in contact.

Advisory Services

Advisory Services Team

Brian Corrigan

John Taylor

Robert J. Meyer, M.D.

Daniel Schultz, M.D., F.A.C.S.

Mark Kramer

David Elder

Maura M. Norden, J.D.

Cynthia Schnedar

Kalah Auchincloss, J.D., M.P.H.

Sandra L. Kweder, M.D.

Karen Midthun, M.D.

Wilson W. Bryan, M.D.

Our Advisory Services

Regulatory Risk Assessments

Regulatory Landscape Series

Regulatory Landscape Series

Success Stories

Conducting Due Diligence to Guide a Corporate Acquisition Decision

Advisory Services Resources

Connect With an Expert

Connect with an Expert - Advisory