Amy McCord, Ph.D., RAC

Senior Regulatory Affairs Consultant


Amy McCord, Ph.D., RAC

With a BS in Microbiology and Cell Sciences and a Ph.D. in Biomedical Sciences from the University of Florida and University of South Florida respectively, Dr. McCord brings over 10 years of technical industry knowledge to her Regulatory background.

With her knowledge of cell based therapies, recombinant proteins, gene therapies, small molecules, vaccines, device and device drug combination products, Amy brings a broad technical experience to her regulatory capabilities. Dr. McCord began her career working on submissions for multiple products at Accentia Bio and Cardinal Health. Amy earned her RAC Certification and is experienced in drafting Module 3 and QOS Module 2 submission content.

Amy provides our clients with authoring capabilities for their submission needs which includes, CMC content, briefing book drafting, submission amendments, and a variety of agency responses. Amy is often asked to provide regulatory affairs risk based guidance in the areas of submission content and strategy. She can drive focused meetings with our internal team and/or a client’s existing infrastructure to meet submission deadlines. Given Dr. McCord’s technical background, she also supports our clients by providing valuable insight and feedback as a Subject Matter Expert on critical development reports or milestones to meet a company’s objectives.

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Core Competencies

  • Agency Type A&B Meetings
  • Oncology & Vaccine
  • Project Management
  • Small Molecule and Device
  • Device/Drug Combo Products
  • Biologics and Biosimilars
  • Orphan Drug Submissions
  • Liposomal Formulations
  • Briefing Books