Greenleaf’s decades of hands-on experience in the regulatory space is unmatched. The firm comprises a team of experts including former leaders and regulatory experts from FDA, Capitol Hill, top global pharmaceutical companies, leading law firms and the top U.S. biotechnology trade organization.
Greenleaf experts work together to provide advisory services that include extensive research and due diligence for investors engaged in potential mergers and acquisitions that require regulatory risk assessments before and after a life sciences transaction.
By using cross-functional areas of expertise, the Greenleaf team is able to set appropriate expectations for investors and provide insights on FDA’s current thinking in key areas.
Greenleaf regularly partners with investors to evaluate potential issues and regulatory risks identified during life sciences transactions.
Greenleaf understands the complex environment within which life sciences transactions take place. This 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 analysis of the following potential sources of risk:
- Marketing authorization
- Manufacturing and quality
- Distribution and supply chain
- Pipeline analysis
- Compliance status
- Product safety
Greenleaf also advises clients regarding how to mitigate regulatory risks once a transaction is completed.