Strategic alignment with regulatory authorities is essential to move your product forward.
Clinigen supports biotech innovators across the full development lifecycle, helping you prepare robust strategies, secure key designations, and meet submission expectations across multiple jurisdictions. Whether you are planning early interactions, pursuing an accelerated pathway or navigating rare disease regulations, we bring deep regulatory insight and hands-on experience to every engagement.
Why choose Clinigen
- Global expertise, specifically in US, EU and UK regulatory strategy, designations and submissions
- 30+ years of experience supporting innovative and unlicensed medicines
- Integrated with our regulatory, PV and medical writing services
Our expertise includes
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
- EMA PRIME
- MHRA Innovative Licensing and Access Pathway (ILAP)
Designations
- Orphan Drug Designation applications and maintenance
- Paediatrics investigation plans and waivers
- Rare disease regulatory strategy
Early Access Programs
- Expanded Access/Compassionate Use program
- Named Patient Programs setup and management
- Pre-submission strategies
Ready to strengthen your regulatory strategy?
Navigate regulatory complexity with confidence. We support your path from early-stage planning to global submission.