Management

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Holly M. Scott is a former FDA/CBER Regulatory IND Reviewer and FDA/ORA Field Investigator with senior level expertise in the following regulatory activities:

  • GMP Inspections/Audits of Biologics, Drug, Cellular Therapy, Combination Products, and Dietary Supplement Manufacturers

  • GCP inspections/Audits of Sponsors, Sponsor-Investigators, Clinical Investigators, IRB, CROs

  • GTP Inspections/Audits of Human Tissue and CAR-T and Cell Therapy Manufacturers

  • QSR inspections/Audits of Medical Device Firms

Holly was a member of the FDA's Biologics Cadre, achieved her Level II FDA Certification, received multiple awards for her job performance, and held temporary detail positions as an FDA Compliance Officer, FDA Supervisory Investigator, and short details as the FLA-DO Director of Investigations Branch. Ms. Scott was instrumental in re-developing the Investigations Branch organization structure to accommodate and train new counter-terrorism hires in 2002. Ms. Scott authored the FLA-DO Dietary Supplement Surveillance Program and was appointed the Dietary Supplement Monitor for the District. With over 33 years of combined service in FDA and consulting, Holly currently assists clients with navigating FDA regulatory processes through audits (PAI, GxP, Mock), BLA support, preparation for regulatory meetings, onsite regulatory inspection support, expert witness services, strategic planning, CAPA remediation, FDA-483/Warning Letter remediation with regulatory response, onsite regulatory meeting representation, data integrity reviews, and in-house Quality Assurance and Compliance support. Additional expertise in EU audit preparation can be provided.