Regulatory Consulting

Leveraging Real World Data to
Achieve Regulatory Success

Real World Data (RWD) is playing an increasingly critical role in health care decisions.  

Strengthening Regulatory Strategies
with Real World Data 

The value of Real World Data (RWD) is recognized by biopharmaceutical companies and the Food and Drug Administration (FDA or Agency) alike. The present challenge for companies is to generate and interpret RWD in ways that the FDA will accept as reliable and fit for use in regulatory decision-making.

Trio Health is proud to be an exclusive partner with Greenleaf Health,
the expert in regulatory guidance

Greenleaf Health (Greenleaf) provides strategic and technical guidance on the effective integration of RWD into regulatory submissions for drugs, biological products, and medical devices. 

The firm works with clients to:
  • Identify opportunities for incorporating RWD into development programs;
  • Ensure that the RWE generated by clients is high quality, accurately interpreted, and meaningful to FDA reviewers; and
  • Present RWE effectively in communications with regulators and in product labeling.