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Heidi Ciliberto specializes in FDA regulatory compliance for companies in the pharmaceutical, medical device, and biotechnology industries. Her background includes significant experience preparing for Food and Drug Administration (FDA) inspections, responding to FDA 483 observations and warning letters, and developing and implementing remediation strategies following a consent decree.
In addition, Ms. Ciliberto also assists with FDA submissions, building EMEA dossiers, and developing and implementing compliance and quality system improvements. Ms. Ciliberto has advised with liquid and suspension manufacturers, active pharmaceutical ingredient (API) manufacturers, and manufacturers of rare disease drugs, anti-infectives, vaccines, targeted immunotherapy drugs, sterile drugs, and all classes of medical devices.
Prior to joining ESi, Ms. Ciliberto served as a go-to resource for pharmaceutical and biotech companies working to identify, develop, and execute remediation strategies to satisfy the requirements of an FDA consent decree. She also consulted with several start-ups, overseeing regulatory compliance matters at virtually every stage of the product lifecycle--from clinical trials through to commercialization.
Ms. Ciliberto strives to help companies develop and implement the quality processes and frameworks that will help ensure that manufactured products are consistently produced and controlled in a way that exceeds FDA regulatory compliance requirements. She understands that a successful quality management system requires buy-in at both the institutional and individual level and strives to create a quality-focused culture that will lead to sustained compliance at each step of the product lifecycle, across the organization.
ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.Contact Us