Jenny Xiradakis

Jenny Xiradakis

Jenny Xiradakis

Principal Consultant

Jenny has more than 16 years FDA experience and is specialized in conducting routine GMP and Pre-Approval inspections and regulating the manufacturing of Sterile/Aseptic Processing, Biotechnology, Pharmaceuticals and Active Pharmaceutical Ingredients (APIs). She has expert knowledge of regulatory requirements to ensure compliance with Good Manufacturing Practices and Good Pharmacovigilance Practices. 

Work Experience

As a former FDA drug investigator, Jenny holds the highest level of FDA certification in cGMP expertise that few investigators have attained since 2011. Jenny held FDA positions as the Director & Regulatory Review Officer at Office of Pharmaceutical Quality/ Office of Surveillance/ Inspection Assessment Branch and the Regional District Drug Expert in NY Drug Inspection Group, Office of Regulatory Affairs. Prior history includes a Senior Staff Pharmacist at the US Department of Justice/Federal Bureau of Prisons and 20 years of service as a Lieutenant Commander of the U.S. Public Health Service Commissioned Corps.

Experience

Jenny holds a B.Sc. in Pharmacy at the Arnold & Marie Schwartz’s College of Pharmacy, Long Island University and completed her Master’s Degree Coursework in Drug Regulatory Affairs with Temple University, Philadelphia. Jenny is also a Licensed Pharmacist and is fluent in Greek.

We are always available for a conversation.

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