Greenleaf Health, Inc. (Greenleaf) is expanding the firm’s advisory services portfolio to include a Regulatory Landscape Series that addresses emerging topics related to FDA regulation. Authored by the firm’s expert advisors, these brief analyses provide valuable, timely insight into the current state and future direction of regulatory developments and activity at the FDA.

Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance on developing regulatory matters. A sample of the series topics includes: 

Medical Device EUAs:  Greenleaf experts provide an overview and analysis of 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. 

COVID-19 Inspections:  Greenleaf compliance experts address FDA inspectional activities during the COVID-19 pandemic and alternative approaches to ensure the continued supply of quality medicines.

COVID-19 Pandemic Accelerates Digitalization of Clinical Trials:  Greenleaf discusses the FDA’s recent support of digital health tools (DHTs) and the impact of digital health technologies in medical product development.

New installments in the Regulatory Landscape Series are published on a regular basis and distributed via Greenleaf e-communication. The complete series is available on the Greenleaf website

The Regulatory Landscape Series is presented by Greenleaf’s Advisory Services Team, which serves as a trusted partner to investors evaluating life sciences transactions. Greenleaf experts provide investors with extensive research and due diligence on potential deals that require regulatory risk analyses before and after decisions and transactions. By working cross-functionally across all areas of expertise, the Greenleaf team is able to offer insight on the FDA’s current thinking in multiple areas and set appropriate expectations for investors. To learn more about Greenleaf’s advisory services, visit the Greenleaf website.

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

To be included in future communications, please register by completing the below form:

Regulatory Landscape Series