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Areas of Expertise

• Develops effective strategies for FDA, as well as other international product applications and registrations
• Devises product development plans -- non-clinical and clinical -- that precisely address regulatory requirements
• Prepares and manages regulatory submissions for FDA and other international regulatory bodies
• Ensures compliance with regulatory requirements and quality assurance and control standards
• Conducts post-marketing surveillance and pharmacovigilance
• Assists with due diligence and product stewardship challenges

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