One Platform.
Three Workflows.
Krevyos unifies CMC Development, Regulatory Affairs, and Quality Assurance into a single structured data ecosystem. No documents. No silos.
Three Domains, One Data Layer
Each module is purpose-built for its domain but shares a common data foundation with the others.
Structure your development data from API synthesis through formulation to manufacturing. Every parameter, every batch, every decision—connected and traceable.
Explore CMC Development- Active substance characterization
- Formulation development tracking
- Manufacturing process governance
- Analytical method lifecycle
Build submissions from live, validated data instead of static documents. When source data changes, downstream filings update automatically.
Explore Regulatory Affairs- Module 3 data assembly
- Impact analysis on changes
- Multi-market submission tracking
- ICH guideline mapping
Maintain audit-ready traceability across every process. Deviations, CAPAs, and change controls flow from the same structured data as your development records.
Explore Quality Assurance- Specification management
- Stability data governance
- Change control workflows
- Audit trail & compliance
Built for How Pharma Actually Works
Every capability is informed by real pharmaceutical workflows, not generic enterprise patterns.
Every entity—substance, product, process, method—is a first-class data object with typed fields, relationships, and full version history.
Change a parameter anywhere and instantly see which downstream documents, filings, and processes are affected.
R&D, Quality, and Regulatory work from the same data. No handoffs, no re-entry, no reconciliation.
Structured data enables predictive analytics, anomaly detection, and intelligent submission optimization. Your data works for you.
21 CFR Part 11, ICH guidelines, ISO IDMP—built into the data model, not bolted on as an afterthought.
Live dashboards across every domain. See your portfolio status, identify bottlenecks, and make data-driven decisions.
Ready to See It In Action?
We walk you through the platform with your own data scenarios. No generic demos, no slides.