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.
Pharma quality agreements
Quality Agreements are an effective bridge to a successful future for companies in the drug development sector. Putting one in place at the start of the business relationship can prevent problems later.