Andrew Bosco, MS

Andrew Bosco, MS

Senior Consultant CMC

Mr. Bosco is an experienced pharmaceutical development professional with over 15 years of industry experience collaborating with small and medium sized Pharma and Biotech companies on early and late stage product development activities. Specializing in a broad range of product development support services, his role within the DRA group focuses on the following areas:

  • Pre-clinical program development and project management
  • CRO/CMO drug substance and drug product vendor management
  • CMC gap analysis for IND, IMPD and NDA regulatory submissions
  • GLP compliance auditing and study monitoring
  • GCP compliance and early phase clinical trial monitoring
  • Early phase (Phase I/II) clinical program management
  • Gap analysis and development of Medical device 510(k) applications

Before joining Dunn Regulatory Associates, Mr. Bosco was the Associate Director of Research at MAP Pharmaceuticals, Inc. He holds a Master’s Degree in Pharmacology and Physiology with a concentration in clinical aerosol science and pulmonary drug delivery from McMaster University, and a BSc in Biology and Pharmacology from McMaster University.