Advisory Services

Experts from Greenleafs Drug, Medical Device, and Compliance Teams provide investors with extensive research and due diligence on potential deals that require regulatory risk analyses before and after decisions and transactions.

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:

  • Product development and review
  • Quality manufacturing
  • Identification of regulatory risk

The result is an unbiased analysis identifying a target company’s key regulatory risks, likelihood of the risks materializing, potential impact on the business, and opportunities to manage and mitigate risks in order to achieve desired regulatory outcomes.

Learn more about Greenleaf’s Advisory Services:

Download Advisory Services Capabilities Deck

Download Advisory Services Info Sheet

GREENLEAF’S ADVISORY SERVICES

SERVICES OVERVIEW

Greenleaf’s advisory services include research and analysis of the following potential data sources:

 

  • Product development
  • Regulatory pathway evaluation
  • Assessment of FDA submissions
  • Compliance status
  • Quality manufacturing
  • Preclinical and clinical quality systems
  • Compliance with reporting requirements
  • Distribution and supply chain
  • Adverse event reporting
  • Marketing and promotion

REGULATORY LANDSCAPE SERIES

Greenleaf’s Advisory Services Regulatory Landscape Series offers insights from Greenleaf professionals on emerging regulatory matters.

 

Medical Device EUAs
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.   Download

 

COVID-19 Inspections
Greenleaf’s second installment of the Regulatory Landscape Series provides an overview and analysis of FDA inspectional activities during the COVID-19 pandemic.  Download

 

COVID-19 Pandemic Accelerates Digitalization of Clinical Trials
Greenleaf’s third installment of the Regulatory Landscape Series provides an overview and analysis of the recent acceleration in the use of digital health tools in medical product development.  Download

 

Advanced Manufacturing Technologies
Greenleaf experts address actions to increase domestic manufacturing capacity and modernize medical product manufacturing, both of which are bolstered by pandemic-related legislation and executive orders. Download

 

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

Advisory Team Members