The United States is the world’s largest health marketplace, accounting for a third of the global market.

The Food and Drug Administration (FDA) centrally regulates drugs, vaccines, blood products, biologics, medical devices, foods and cosmetics – with increasing scrutiny. The Affordable Care Act (ACA) is perceived by many as the first step in the direction in controlling drug costs and reducing overall healthcare expenditure, which leads sponsors to start collecting reimbursement data and advice in addition to scientific advice from the FDA.

Located in Kendall Square in Cambridge, Massachusetts, the VCLS US team supports domestic and international clients with their interactions with the FDA, Institutional Review Boards (IRBs) and insurers, as well as Health Canada.

  • Authoring/review and submissions
  • Regulatory forms and labeling
  • Investigational New Drug application (IND)
  • Investigational Device Exemption application (IDE)
  • New Drug Application (NDAs) / Biologic License Application (BLAs)
  • Pre-Market Notification (510(k)) / Pre-Market Approval (PMA)
  • Orphan Drug Designation (ODD)
  • Fast Track Designation request
  • Breakthrough Therapies Designation request
  • Product Classification designations (e.g. combination products, device designations)
  • CTD format and publishing
  • Submission (FDA Electronic Submission Gateway)
  • Pediatric Study Plans and Proposed Pediatric Study Requests
  • Safety reporting
  • US Agent for foreign companies
  • Pre-Approval Inspection readiness
  • Small business exemptions
  • Preparation for strategic meetings
  • Identification of questions
  • Preparation and submission of briefing packages
  • Participation in Type A, B and C, VXDS meetings with FDA
  • Debriefing, assessment of FDA feedback, written answers to FDA
  • Clinical Trial Applications (CTAs)
  • New Drug Submissions (NDS)
  • Safety reporting
  • Pre-NDS Meetings
  • Pre-CTA Meetings