Geoff Garabedian

Practice Leader - Regulatory and Quality - U.S.

As Practice Leader for Regulatory and Quality in the U.S., Geoff combines a strong management consulting background with specific experience in the regulatory and compliance arena, including design and implementation of large-scale process, organization and technology transformations.

Prior to joining Quintiles, he led the Regulatory Affairs, Medical Affairs, Clinical Development, and Pharmacovigilance practice areas at BusinessEdge Solutions, where he was a Partner. The Regulatory Affairs practice, which he helped established, provided solutions for Global eSubmissions Process Optimization, eCTD Strategy and Implementation, Document Management and Publishing, CMC Change Control, Regulatory Product Submission Tracking, Lifecycle Risk Management Processes, and Regulatory Strategy development.

Prior to BusinessEdge, Geoff was with Accenture's Life Science practice for over 11 years, where he focused on process optimization and technology enabled solutions within Regulatory Affairs, Compliance and Clinical Development.

Geoff’s experience in the compliance space includes: SOP Development, Computer Systems Validation, Clinical Site Audits, Risk Assessment/Mitigation, Global AE Reporting and Product Quality Complaints, as well as process analysis and modeling.