R&D / Early Stage
Compliance before the first IND
Build an audit-ready documentation backbone from day one — no painful remediation when the FDA inspection arrives.
KOŚA for Biotech & Startups
GxP-ready from seed to commercial.Scale without re-platforming.
For Series A–C biotech that needs enterprise-grade compliance infrastructure before the first FDA inspection — at a price that fits a startup burn rate.
Why biotech chooses KOŚA
Built for teams racing toward the clinic.
Lean-team pricing, API-first architecture and a deployment that keeps up with your funding rounds — not one that drains them.
Clinical / CMC
Scale from lab to pilot plant
One platform that grows with you — from analytical method validation to commercial batch release, without re-platforming.
Finance / Ops
Investor-grade compliance ROI
Predictable SaaS costs, fast deployment and defensible audit trails that satisfy both VCs and regulators.
60 days
From contract to first audit-ready site
50%
Lower upfront cost vs. legacy suites
Elastic
Pay-per-user that scales with headcount
99.9%
Uptime SLA — no infrastructure team needed
One platform, every stage
From seed to commercial — no re-platforming.
Start with DMS + LMS on a lean team plan. Add QMS, E-BMR, LIMS and Material Management as you hit CMC, IND and BLA milestones — on the same validated stack.
60-day go-live
Audit-ready DMS + LMS deployed fast — not in quarters.
Elastic per-user pricing
Pay for who you have now. Add seats as you hire, without renegotiation.
API-first architecture
REST APIs and webhooks that fit your existing data stack — ELN, LIMS, ERP.
Investor-ready audit packs
Generate regulatory readiness reports for board decks and due diligence.
Growth journey on KOŚA
1
Series A
DMS + LMSSOP control & team training
2
Series B / IND
+ QMS + LIMSDeviations, CAPAs, analytical
3
Series C / BLA
+ E-BMR + Material MgmtCommercial batch & release
Connected modules
See all 13 modules →Start lean. Layer as you grow.
Begin with DMS + LMS on a startup plan. Add QMS, LIMS, E-BMR and Material Management as your pipeline advances — all on the same validated stack.
Document Management (DMS)
Controlled SOPs, protocols and reports — with change control and role-based approvals from Series A.
Learning Management (LMS)
GxP training and OJT attestation for lean teams — track compliance even when your headcount doubles every quarter.
Quality Management (QMS)
Deviations, CAPAs, change control and risk — scaled to your team size, not an enterprise sales process.
Electronic Batch Records (E-BMR)
Paperless batch execution with in-line e-signatures — ready when you hit your first commercial run.
LIMS
Sample lifecycle, instrument integration and COA generation — from early analytical development to release testing.
Material Management
Traceability from cell bank to vial — receipt, sampling, status control and dispensing as you scale.
Outcomes
What changes the day you go live.
KOŚA gives your lean team enterprise-grade compliance infrastructure — without the enterprise sales cycle, implementation risk or burn-rate shock.
60-day deployment guarantee
DMS + LMS live, validated and inspection-ready in 60 days — backed in writing.
Compliance by design
Investor-grade. Regulator-grade. From day one.
Every action signed, timestamped and immutable. Every record ALCOA++ aligned. Generate regulatory readiness reports for your next board meeting or FDA pre-sub.
21 CFR Part 11
EU Annex 11
ALCOA++
GAMP 5
WHO Data Integrity
ICH Q5A–Q5D (Biologics)
"We went from zero GxP infrastructure to an FDA-ready quality system in 8 weeks. Our investors loved the audit pack. Our QA team loves the platform."
VP of Quality, Series B biotech (cell therapy)
See KOŚA running your quality roadmap.
45-minute demo with a compliance architect — bring your IND timeline, we’ll show you how to get inspection-ready.