Track Record of Execution
GenZen’s team has an experience of successfully developing and obtaining regulatory approvals for more than 300 products across major international markets, including the United States (FDA), European Union (EMA), Japan and Canada (Health Canada). This track record reflects:
Strong project management across multi-year development programs
Capabilities in clinical study design, bioequivalence testing, and regulatory filing
A deep understanding of international regulatory pathways and compliance standards
This proven ability to bring complex products through the regulatory process underscores GenZen’s value as both a development partner and an investment platform.