Advisory Services

Greenleaf regularly partners with investors to evaluate potential issues and regulatory risks identified during life sciences transactions.

Greenleaf’s decades of hands-on experience in the regulatory space is unmatched. The firm’s team of experts includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization.

Experts from Greenleaf’s drug, device, and compliance teams work together to provide advisory services that involve extensive research and due diligence for investors engaged in potential mergers and acquisitions that require regulatory risk analyses before and after decisions and transactions. By working cross-functionally across our areas of expertise, Greenleaf is able to set appropriate expectations for investors and offer insights on the FDA’s current thinking in diverse areas.

Greenleaf understands the complex environment within which life sciences transactions take place, which is why the firm considers multiple aspects of a business when performing advisory services, including product development, compliance, enforcement, manufacturing, and regulatory submissions.

GREENLEAF'S ADVISORY SERVICES

Greenleaf’s advisory services include research and exploration of the following potential sources of risk:

  • Marketing authorization
  • Manufacturing and quality issues
  • Promotion
  • Distribution and supply chain
  • Pipeline analysis
  • Compliance status
  • Labeling
  • Product safety

Greenleaf also advises clients regarding how to mitigate regulatory risks once a transaction is completed.

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Advisory Team Members