Our Services
At Kalvion Sciences, we partner with life sciences organizations to unlock value across the product lifecycle.
DMPK & Clinical Pharmacology
Advanced modeling and simulation for drug development decisions.
Learn moreDMPK & Clinical Pharmacology
Advanced modeling and simulation to optimize drug development decisions and accelerate your path to market.
Our services include:
- Non-compartmental analysis (NCA) for all clinical phases
- Population PK/PD modeling for dose optimization
- Exposure-response analysis and clinical trial simulations
- Disease progression modeling and biomarker analysis
- Quantitative systems pharmacology (QSP) modeling
- Pediatric dose extrapolation and special populations
- Regulatory submission support (FDA, EMA, PMDA)
Value delivered:
Accelerated development timelines, optimized dosing strategies, reduced clinical trial costs, and robust regulatory packages.
Regulatory Affairs
End-to-end regulatory strategy and global submission support to navigate complex regulatory landscapes.
Our services include:
- Regulatory strategy development and gap analysis
- IND, NDA, BLA submissions (FDA)
- MAA, CTA submissions (EMA)
- JNDA, J-IND submissions (PMDA)
- Orphan drug and breakthrough therapy designations
- Regulatory meeting preparation and support
- CMC, preclinical, and clinical documentation
Value delivered:
Streamlined approval pathways, reduced regulatory risks, faster time to market, and successful global registrations.
Value, Access, Pricing & Reimbursement
We ensure your innovations reach patients by building sustainable access pathways.
Our services include:
- Access strategy development
- Launch price optimization
- Reimbursement submissions and HTA support
- HEOR strategy and real-world evidence planning
- Cost-effectiveness and budget impact modeling
- Patient access program design and implementation
- Value dossier development and targeted literature reviews
Value delivered:
Improved payer engagement, data-driven pricing, and regulatory-aligned market entry.
Why Partner With Us
Specialized Expertise
Deep understanding of biopharma, medtech, and diagnostics sectors.
Tailored Solutions
Customized to your market context and organizational needs.
Impact Focus
Every engagement tied to measurable business and patient outcomes.
Get in Touch
Ready to unlock value across your product lifecycle? Let's discuss how Kalvion Sciences can help drive your success.