Global Compliance & GCP
Have you taken the most effective regulatory pathway?
Navigating global compliance goes beyond regulatory risks
We’ll equip you to stay compliant – and safe
Today’s regulatory environment has the potential to reform clinical monitoring and trial management and shift focus to standards of quality and safety for medical devices while helping accelerate product development and bring new innovations and advances to patients who need them faster and more efficiently. We’re highly focused on protecting patient data and staying current with the new regulatory guidance that governs this rapidly changing industry.
We constantly monitor a regulatory intelligence database to manage the compliance issues facing the industry, and our study start-up professionals and regulatory strategists share this insight with clients to ensure their access to robust data within the scope of evolving global compliance rules.
Whether it’s FDA regulations, investigational new drug (IND) applications, good clinical practice (ICH GCP standards), or other regulatory and compliance hurdles, we can lead you to the best opportunity for successful medical device and product development outcomes.
5 tips to avoid an IND clinical hold
A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies.
Pathways to expedited drug development
Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient.