Our Services

  • Product Safety Reviews
  • Responding to FDA/EMA  PV audits & inspections, 483s and Warning Letters 
  • Benefit-Risk Analyses
  • Choosing a safety CRO & out-sourcing safety
  • Product Withdrawals and Recalls
  • Signal Detection & Analysis
  • Risk Management
  • Mock Advisory Committee Meetings
  • Regulatory Safety & PV Strategy
  • Negotiations with Regulators
  • Ad hoc Consulting to the PV, Drug Safety, Risk Management & Regulatory teams 
  • Data Safety Management Boards (DSMBs) & Data Monitoring Committees (DMCs)
  • Safety Crisis Management