Medical and Regulatory Affairs
Does your study design satisfy regulatory requirements from an FDA perspective?
We can help you avoid surprises
Early strategic input places – and keeps – your trial on track
Our medical and regulatory affairs team brings specialists’ knowledge to your trial to study the data and understand the risks. And with deep regulatory knowledge of every country where we conduct clinical trials, we know the rules – even when they changed yesterday. That means we can select the optimal pathways and devise the most efficient way to design and run your study.
Developing an orphan drug? Our success in pursuing novel applications has led to immediate increases in valuation for biotech firms, creating leverage for additional fundraising. We focus on staying ahead of the technology curve. For example, we began electronically submitting IND applications long before the FDA started mandating e-submissions in 2018.
Our medical and regulatory affairs team engages with sponsors early, before they enter human trials, coordinating closely with our medical, statistics, operations, and medical writing teams.
PREMIER INSIGHT 268
We said yes
The client asked the nearly impossible – a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it.
FDA’s updated guidance
In 2019, the U.S. Food and Drug Administration updated its draft guidelines for drug discovery in rare diseases. The changes can help sponsors perform more efficient development programs and gain new insights on the development process.