Solutions across the GxP landscape

One compliance OS for every life-sciences team.

From mid-market pharma to CMOs, biotech startups and CROs — KOŚA delivers the same modern compliance backbone, configured to how your organisation actually works.
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Who we serve

Four segments. One compliance backbone.

Every team has different jobs-to-be-done. Pick the one that sounds like yours — we'll show you the exact configuration, KPIs and rollout plan.

Each solution comes with: pre-built templates, role-based dashboards, regulator mapping (FDA, EMA, CDSCO, WHO-GMP), and a 90-day rollout playbook.
Primary

Pharmaceutical Manufacturers

For mid-market pharma stuck between expensive legacy contracts and risky Excel + SharePoint workflows.

50% lower compliance cost

  • Achieve FDA / EMA inspection readiness in 90 days
  • Reduce compliance management costs by 50%
  • Centralise training & certification across distributed sites
  • Ensure SOP adoption with tamper-proof audit trails
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Secondary

Contract Manufacturers (CMOs)

Operate multiple client programmes from a single, tenant-isolated platform.

Multi-tenant ready

  • Manage SOPs for multiple clients with strict tenant isolation
  • Rapid customer onboarding via pre-configured templates
  • White-label tenant-branded portal (planned Q3 2026)
  • Per-client audit reports without manual reconciliation
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Tertiary

Biotech & Startups

For Series B/C biotech that needs enterprise-grade systems before the first FDA inspection.

Inspection-ready in 60 days

  • Stand up GxP infrastructure ahead of clinical milestones
  • API-first platform that fits modern engineering stacks
  • Predictable SaaS pricing aligned to startup budgets
  • Scale from one site to many without re-platforming
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Quaternary

CROs & Clinical Research

Centralise training, documents and OJT attestations across multi-site studies.

Sponsor-ready packages

  • Training compliance for multi-site, multi-protocol studies
  • Regulatory documentation management at study scale
  • On-the-job training attestation with supervisor e-signature
  • Sponsor-ready audit and inspection packages on demand
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Why teams pick KOŚA

Modern compliance, without the enterprise tax.

Built for the regulator's perspective, priced for emerging-market budgets, architected for distributed manufacturing.

90 days
Average rollout to first audit-ready state
50%
Reduction in compliance management cost
13
Modules across the GxP lifecycle
100%
21 CFR Part 11 e-signature coverage

Don't see your exact use case?

We've configured KOŚA for hospital pharmacies, API manufacturers, medical device firms and more. Tell us your context — we'll map it to the right modules.

Talk to a compliance architect