Services

  • Regulatory Strategy Consulting
    • Critical program review and regulatory issue analysis
    • Regulatory risk analysis and mitigation strategy planning
    • Critical review of advertising and promotional materials – for pre-launch activities or for marketed products
    • Comprehensive regulatory CMC services including¬†development planning
    • Expert consulting on regulatory¬†key scientific¬†topics such as QT prolongation, suicidality assessment, abuse potential
    • Due diligence for licensing and investment decision making
    • Label development
  • Comprehensive Regulatory Meeting Planning & Execution
    • Initial meeting planning
    • Meeting request and briefing document
    • Rehearsals and team preparation
    • Meeting conduct and follow up
  • Regulatory Submissions
    • Preparation and submission of initial INDs
    • Maintenance of existing INDs
    • Expert consulting on CTD build for US NDAs and EU MAAs
    • Maintenance of existing NDAs and BLAs
  • Document Formatting & Publishing
    • Document formatting (consistent styles, headers/footers, tables of contents, etc)
    • Document/report publishing (compliant with eCTD standards with bookmarks and hyperlinks)
    • Compilation of Clinical Study Reports

Click here for our Services Brochure