Contact ASV Regulatory Consulting, LLC


Name:
Phone:
Email Address:*
Comments:
* required
Andrew S. Verderame
27 Beech Tree Ridge
Killingworth, CT 06419
office - 860.663.8023
Selected Accomplishments
  • Full presentation to FDA Advisory Committee resulting in unanimous committee vote for product approval
  • Four NDA approvals as corporate FDA liaison, dozens of sNDA and labeling approvals
  • Served as regulatory lead at more than 100 face-to-face meetings and teleconferences with FDA
  • First industry representative ever invited to speak at FDA Project Manager Forum
  • Team Leader for successful pediatric exclusivity FDA negotiations, resulting in more than $500 million in additional sales
  • Experienced in fast-track applications, special protocol assessments, and orphan drug designations
  • Skilled in anti-infective, anti-viral, oncology, respiratory, metabolics, CNS, and other therapeutic areas
© ASV Regulatory Consulting, LLC website by PurpleDog