Navigate complex regulatory landscapes with confidence.
Regulatory strategy & submissions
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