Regulatory Intelligence

  • Real-time regulatory landscape monitoring
  • Competitive intelligence and pathway analysis
  • Region (country) specific requirement mapping
  • Strategic timeline development

Accelerated Pathways

  • Fast Track designation strategy and applications
  • Breakthrough Therapy designation support
  • Priority Review pathway optimisation
  • Regenerative Medicine Advanced Therapy (RMAT) guidance

Designations

  • Orphan Drug Designation applications and maintenance
  • Paediatrics investigation plans and waivers
  • Qualified Infectious Disease Product (QIDP) designations
  • Rare disease regulatory strategy

SME and Early Access Programs

  • Scientific Method Exchanges (SME) preparation and execution
  • Expanded Access/Compassionate Use program
  • Named Patient Programs setup and management
  • Pre-submission strategies