IRB/EC/REB Regulatory Submissions

The GLOBAL CRO Approach

The regulatory demands of clinical trials are complex and always changing. Here at GLOBAL our regulatory experts assist teams navigate workflows with ease. Our Regulatory Affairs team can support any project whether it is just getting off the ground or has post-market needs.

Our Consulting Services Include:

• Regulatory Strategies

• Country Submissions (US and OUS)

• Central/Local IRB/EC Submissions

• Regulatory Reporting

• Support for FDA pre-sub meetings and filings

• FDA Panel Support

• Regulatory Audit preparation/support

• Special status filings with FDA such as breakthrough designation and STEPs

Why Choose GLOBAL CRO?

Early and critical strategic work must take place in the regulatory setting by assuring proper country selection for maximal enrollment with reliable data.  The Global team can assist with the regulatory strategy development, provide services for local and national regulatory agency submissions and keep you in compliance with reporting requirements for each geography.  

For FDA submissions, we can support and provide proper documentation for the process, all the way from early Q-sub meetings to final submissions and support with FDA panels and labeling negotiations.  If you need a post-market study in any geography, we can support that too.