Regulatory Consulting and Support

Theradex provides regulatory support and consulting services to the pharmaceutical industry across a wide range of therapeutic approaches including new chemical entities, cancer vaccines, and biologics including gene therapies, monoclonal antibodies and oncolytic viruses. Our regulatory team also assists our clients with Orphan Drug Applications to both FDA and EMA.

Regulatory Services:

  • Regulatory/Development Strategy Consulting
  • National or Central Scientific Advice Meeting Preparation and Attendance
  • FDA Development Cycle Meetings
    • Pre-IND
    • End of Phase I/II
    • Pre-NDA
  • Specialized Therapy Product Development
    • Gene Therapies
    • Cell Therapies
    • Tissue Therapies
    • Combination Products
  • Application Preparation in CTD Format
  • Pre-IND, IND Application and IND Maintenance
  • Pre-submissions, Package Preparation and Meetings with CDRH
  • Core Document Preparation and Approval- Electronic Submissions
  • Investigational Medicines Product Dossier (IMPD) Preparation
  • Development Safety Update Reports (DSURs)
  • Small to Medium Enterprise (SME) Registration
  • Clinical Trial Applications
  • Pediatric Drug Development Plans
  • New Drug Applications