SYNERGY
Our Founder
Anu Gaur
PhD, Exec. MBA, MSRA, RAC (US & GLOBAL)
Anu Gaur is an expert in the US FDA & Global Regulatory Affairs, Quality Assurance, and Post-Market Compliance. Dr. Gaur has gained extensive experience in the Medical Devices (Class I, II, III manufacturing environments), & Pharmaceuticals/Biotechnology sectors, constituting 18+ years of commercial industry experience in multiple therapeutic indications.
Dr. Gaur has established an excellent reputation in the life sciences industry demonstrating in-depth knowledge and outstanding leadership while executing strategies for the Pre-market & Post-market compliance and Product Lifecycle Management (LCM) management, and leading the global regulatory agencies communications for all global zones, including 80+ major global markets constituting the US, EU, LATAM, CANADA, JAPAN, APAC, EMEA, Middle East, South Africa, ROW and Islandic regions.
Additionally, Dr. Gaur has successfully led and managed Global Recalls and reconciliations, Risk Management strategies and implementation, CAPAs, MDRs, and Safety Reporting. Her vast international regulatory affairs experience also includes leading strategies for QMS implementation, MDSAP, EU MDR, ISO 13485 Recertification, and EU Notified Bodies (NB) Transfers.
Dr. Gaur is a PhD-Scientist and an Executive MBA, and has attained graduate degrees in Chemistry, Regulatory Affairs for Drugs, Biologics and Medical Devices, and Graduate Certifications in Domestic Biopharmaceuticals Regulatory Affairs and Clinical Trials Design and Project Management. Dr. Gaur has earned her Regulatory Affairs Certification (RAC) Designation for the United States (RAC-US) and GLOBAL (RAC-GLOBAL).
Connect with Anu Gaur via LinkedIn here