Michael Higgins

Higgins Pharma Consulting Group
Sr. Regulatory Compliance Consultant
Michael is a well-established Senior Regulatory Compliance leader with practical and extensive experience in the application and implementation of GMP regulations. He is recognized for expertise in advising internal and external stakeholders on GMP matters and is a critical thinker with the highest integrity. Michael has broad and diverse strategic experience in a variety of Compliance-related functions. He is an accomplished SME in a number of areas including Audits, Investigations, Supplier Quality, Inspection Mgt, Regulatory Intelligence/Policy and GCP/PV. He was a former FDA Field Investigator and member of the Mid-Atlantic Regional Drug Cadre and conducted GMP inspections, both domestically and internationally, some of which led to Official Actions by the FDA such as Warning Letters, Mass Seizures, and Consent Decrees. Michael holds a Bachelor of Science in Chemistry from Binghamton University, NY, and an MBA with Honors from Iona College, NY. As a Consultant and Advisor, Michael is currently providing expert FDA compliance solutions to clients with a focus on continuous improvement and sustainability tailored to their unique needs. He is based in New Jersey.