Being properly prepared for interacting with regulatory agencies on drug development is crucial to successful clinical studies. Overcoming regulatory hurdles and implementing the appropriate guidelines can be challenging, leading to missed opportunities and costly delays to market access.
Successful regulatory approvals are built on appropriate pre-planning and execution based on a deep understanding of the regulatory landscape and options. At Exploristics we offer a unique insight based on our experience of years of working with regulatory bodies and having contributed to the development of regulatory procedures.
Working alongside the FDA, we have:
- conducted collaborative research and delivered informative workshops;
- participated in scientific advice and pre-submission meetings; and
- supported our clients through regulatory submissions.
Our customers not only benefit from our unique vantage point by gaining distinctive insights on acceptability and adherence, but from our ability to move beyond the routine and develop novel statistical solutions for study design and analysis.