Hetal Mithani
Medical Regulatory Consultant at Independent Consultant | Ashburn, Virginia, United States
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Hetal Mithani is a dedicated Medical Regulatory Consultant with extensive experience in optimizing internal controls and enhancing core business capabilities within the healthcare sector. Currently serving as an independent consultant, Hetal leverages his comprehensive medical and regulatory expertise to analyze and refine existing controls, ensuring robust performance and operational continuity for his clients. His strategic insights are particularly valuable in navigating the complex landscape of regulatory compliance, especially for startups and established firms looking to expand their market presence.
One of Hetal's notable achievements includes his role at SORISA in Barcelona, where he successfully designed a new strategy to pivot the positioning of aesthetic medical devices from European markets to the U.S. This involved conducting a thorough U.S. market analysis that identified optimal product penetration points, enabling the company to tailor its approach effectively. Hetal's leadership in spearheading new projects and fostering third-party relationships was instrumental in securing FDA approval for these products, thereby facilitating their entry into the competitive U.S. market.
His expertise spans various domains, including CMC regulatory affairs, clinical development, and healthcare management, making him a versatile asset in the lifesciences industry. Hetal's proficiency in research skills and knowledge acquisition further enhances his ability to provide actionable insights that drive compliance and innovation. As he continues to support clients in navigating regulatory challenges, Hetal remains committed to advancing healthcare solutions that prioritize safety, efficacy, and market readiness.
Medical Regulatory Consultant at Independent Consultant in January 2012 to Present
Director of Medical Affairs / Executive Representative of Regulatory Affairs & QA at Human BioSciences, Inc. USA in January 2009 to January 2011
Project Manager - Real Estate Development at Sig Inc in January 2004 to January 2008
Research Assistant - Department of Anesthesiology at University of North Carolina at Chapel Hill in January 2001 to January 2003
Pediatric Resident at Atlantic Health System in January 2000 to January 2001
Pharmacy Technician at Memorial Sloan Kettering Cancer Center in January 1994 to January 1995
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Boston University, Bachelor of Arts - BA
Ross University School of Medicine
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Analytical Skills
Data Analysis
Teamwork
Medical Education
Regulatory Compliance
Startups
Research Skills
Knowledge Acquisition
CMC Regulatory Affairs
Healthcare Management
Stakeholder Engagement
Clinical Research
Regulatory Affairs
Medical Devices
Lifesciences
Clinical Development
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Discover more about Independent ConsultantWhat is Hetal Mithani email address?
Email Hetal Mithani at [email protected]. This email is the most updated Hetal Mithani's email found in 2026.
What is Hetal Mithani phone number?
Hetal Mithani phone number is 5713674372.
How to contact Hetal Mithani?
To contact Hetal Mithani send an email to [email protected]. If you want to call Hetal Mithani try calling on 5713674372. (updated on September 01, 2024)
What company does Hetal Mithani work for?
Hetal Mithani works for Independent Consultant
What is Hetal Mithani's role at Independent Consultant?
Hetal Mithani is Medical Regulatory Consultant
What industry does Hetal Mithani work in?
Hetal Mithani works in the Biotechnology industry.
Hetal Mithani Email Addresses
Hetal Mithani Phone Numbers
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