ASV Regulatory Consulting, LLC
ASV Regulatory Consulting provides US FDA regulatory consulting services to biotechnology and pharmaceutical companies. We are dedicated to assisting clients move product candidates efficiently from the research and development stage through clinical trials and FDA review and into commercialization. Andrew Verderame is a FDA specialist who provides valuable insight to his clients in meeting U.S. regulatory, quality and clinical study requirements.
About Us:
Andrew Verderame is a regulatory affairs executive with over 20 years of pharmaceutical experience and a proven record of obtaining FDA approvals, building working relationships with FDA, and managing regulatory teams that accomplish both group and company goals. A seasoned and versatile professional, he is experienced in both the large pharmaceutical and biotech business models. He offers outstanding industry knowledge and human relations skills that promote candor and build trust. By applying insightful analysis and initiative, he is able to offer innovative regulatory solutions for organizations in both the drug development and commercialization phases.
Services:
We provide short-term (project based) or long-term consulting services for your FDA regulatory strategy, clinical development, and promotional material review needs. ASV Regulatory Consulting has extensive FDA experience to help your company exceed your business objectives and shorten your timelines.
  • Regulatory/Clinical Development strategy
  • Preparation and facilitation for FDA meetings (including preparation or review of meeting requests and briefing packages and conducting rehearsals) at all stages of product development and commercialization
  • Representation of clients to FDA
  • Promotional material review and submission
  • Due diligence (inlicensing/outlicensing) expertise
  • Regulatory strategic on-site team leadership
  • Regulatory submission preparation and review
  • Regulatory intelligence
  • Whatever your regulatory need - please contact us. We are ready to help.
Andrew S. Verderame
27 Beech Tree Ridge
Killingworth, CT 06419
office - 860.663.8023
cell - 203.675.8361
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