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