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Regulatory Strategy

Sandy helps her clients anticipate and meet clinical trial, and drug safety /pharmacovigilance requirements in the US and Europe. She and her colleagues ensure an initial clinical trial application (e.g., an IND for FDA) is complete and concise, facilitating its prompt, successful regulatory authority review. She then maintains the IND/CTA by filing protocol amendments, development safety update reports, time-sensitive safety information for clinical trial patients, and ensures all project regulatory requirements are met (but no extra work is done) achieving project efficiency. Sandy frequently interacts with FDA staff to ensure projects stay on track. When a product is also being developed in other world regions, Sandy takes into account those regional requirements/status for project efficiency across regions (most frequently the US and Europe).

Because Sandy lives works a short distance from FDA, she participates in public information-providing FDA and FDA Advisory Committee meetings relating to issues that affect her clients, or that just interest her.