Regulatory Strategy Services

  • Global regulatory strategy for new and advanced development programs
  • Global regulatory strategy for lifecycle management of marketed products
  • Regulatory pathway assessment, strategy and implementation
    • Orphan Designation
    • Pediatric
    • Fast Track
    • Breakthrough Therapy Designation
    • Priority Review
    • Accelerated Approval
  • Regulatory Application planning and preparation
  • FDA Meeting planning, preparation, representation
    • Pre-IND
    • End of Phase 2
    • Pre-NDA
    • Late-Cycle Meetings
  • Regulatory functional leadership and representation for cross-functional teams
  • Agency liaison for all interactions with regulatory authorities
  • Global clinical strategy across all phases
    • Clinical trial planning and protocol review
    • Study start-up consultation
  • Global regulatory intelligence
  • All therapeutic areas, small molecule, biologics and combination products

Request for Regulatory Strategy Services

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