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Braulio Ortiz

Principal Consultant
BioTeknica, Florida, United States

Braulio Ortiz, M.B.A.

Braulio Ortiz is co-founder and Principal of BioTeknica, an IQVIA inc. business unit focusing on regulatory compliance and engineering consulting services. He has extensive experience in regulatory compliance, quality systems, engineering, process validation, and manufacturing for the biomedical, pharmaceutical and medical device industries.

Braulio has co-led Third party consulting efforts for companies that have received FDA warning letters and firms that were under FDA consent decree. He is a former Director of Quality Systems, Director of Engineering, and Director of Operations for Baxter Healthcare. He has assisted leading Medical Device and Pharmaceutical clients address regulatory compliance issues as well as navigate FDA site registration, qualification, and inspection for new plant start-ups. Additionally, he has served as an expert witness for Pharmaceutical and Medical Device Regulatory Compliance litigation in $1billion lawsuits.

On the philanthropy end, Braulio is board chair for the Medical Advisory Committee for the SebastianStrong foundation that funds pediatric cancer research.

Braulio earned his Bachelor of Science degree in Chemical Engineering from Cornell University in 1983, and his Master of Business Administration from the University of Miami in 1996.

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