Smart planning. Hands-on support. Faster, clearer regulatory paths.
Your regulatory strategy isn’t just about compliance—it’s about enabling clinical progress, unlocking designations, and creating BD value. At JRC, we work with biotech companies to craft efficient, globally aligned regulatory strategies and deliver hands-on support from pre-IND through approval.
U.S. & Global Regulatory Pathway Design
We help you define the optimal approval path and ensure your development plans are aligned with agency expectations.
- Regulatory feasibility assessment
- FDA/EMA pathway strategy
- Fast Track, Breakthrough, PRIME, Orphan Drug Designation
- Timeline modeling and risk analysis
IND-Readiness & Scientific Agency Interactions
We guide you through early regulatory engagement and help you prepare for productive meetings.
- Pre-IND planning and document preparation
- Meeting question development and rehearsal
- Participation in FDA/EMA meetings
- IND gap analysis and dossier readiness
Submission Management & Execution
Our experts deliver complete IND/CTA submission support—from strategy to eCTD delivery.
- End-to-end IND/CTA preparation
- Preclinical data review with toxicologists/pharmacologists
- eCTD publishing and document QC
- Response strategies for regulatory feedback
What Makes Us Different
- Integrated regulatory + clinical planning from day one
- Proven success with expedited pathways and FDA designations
- Scalable support—strategic, operational, or interim RA leadership