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