KOŚA for Contract Manufacturers (CMOs)

One platform. Every sponsor.Isolated, audited, ready for inspection.

Stop standing up a new compliance stack for every client. KOŚA runs every sponsor programme on a single, tenant-isolated, audit-ready platform — at 40% of the cost.
Why CMOs choose KOŚA

Built for shops that serve many sponsors.

Tenant isolation, per-client audits and template-driven onboarding — purpose-built for the operational reality of contract manufacturing.

Client Programmes

Isolate every client, share nothing

Strict per-tenant SOPs, training matrices and batch records — with zero risk of cross-client data leakage.

Business Development

Onboard new sponsors in days

Spin up a new client tenant from pre-configured templates — pricing, audits and inspection packs included.

Quality & Inspections

One audit per sponsor, not per system

Generate per-client audit reports on demand — no manual reconciliation across paper, SharePoint and Excel.

5 days

Average new-client tenant onboarding

40%

Lower TCO vs. one system per client

Unlimited

Client tenants on a single platform

100%

Tenant data isolation — verified

Multi-tenant by design

One operator. Many sponsors. Zero crossover.

Every client gets a strictly isolated tenant with its own SOPs, training matrix, batch records and audit trail — while your operators move between programmes with a single sign-on.
  • Strict data isolation

    Row-level + workspace isolation. Audited regularly.

  • Shared master templates

    Reuse SOP skeletons across clients while keeping content isolated.

  • Sponsor-branded portals

    White-label tenant UI and audit packs (planned Q3 2026).

  • Days-not-quarters onboarding

    Spin up a new client tenant from a proven template.

  • KOŚA platform — single deployment

    Sponsor A

    • Tenant SOPs
    • Training matrix
    • Batch records
    • Audit trail
    Sponsor B
    • Tenant SOPs
    • Training matrix
    • Batch records
    • Audit trail
    Sponsor C
    • Tenant SOPs
    • Training matrix
    • Batch records
    • Audit trail
    Shared operators · single sign-onZero cross-tenant access
    Connected modules

    Every module, multi-tenant aware.

    Start with DMS + LMS scoped per sponsor. Layer QMS, LIMS, E-BMR and Material Management as your client roster grows — on one audit-ready stack.

    See all 13 modules →

    Multi-Tenant DMS

    Client-isolated SOPs with shared master templates, change control and watermarked release copies.

    Cross-Client LMS

    One operator, many client curricula — role-based GxP training with per-sponsor certification reports.

    QMS per Tenant

    Deviations, CAPAs and change control scoped to each sponsor — with shared site-level KPIs for ops.

    Electronic Batch Records

    Sponsor-specific E-BMRs with in-line e-signatures, exception management and signed PDF release packs.

    LIMS

    Per-client sample lifecycle, instrument integration and COA generation — branded to each sponsor.

    Material Management

    Segregated client inventory, sampling and dispensing — traceable from goods-in to sponsor release.

    Outcomes

    What changes for your CMO the day you go live.

    KOŚA replaces fragmented per-client systems with one validated platform — designed by compliance architects who’ve passed sponsor and regulator audits.

    5-day client onboarding

    New sponsor tenant — SOPs, training and audit packs — live in under a week.

  • Manage SOPs for multiple sponsors with strict tenant isolation
  • Onboard new clients in days using pre-configured templates
  • Generate per-client audit packs without manual reconciliation
  • Run sponsor inspections from a tamper-proof, scoped audit trail
  • Bill clients accurately with per-tenant usage and storage metrics
  • Offer white-label, sponsor-branded portals (planned Q3 2026)
  • Compliance by design

    Sponsor-ready. Regulator-ready. Always.

    Every action signed, timestamped and immutable — per tenant. Every release backed by a validated change control trail your sponsors can audit anytime.

    21 CFR Part 11
    EU Annex 11
    ALCOA++
    GAMP 5
    WHO Data Integrity
    ICH Q7 (API CMOs)
    "We onboard new sponsors in a week, not a quarter. Every client gets their own audit pack on demand — and our last three sponsor inspections closed with zero findings."
    Director of Quality, multi-site Indian CMO

    See KOŚA running your sponsor programmes.

    45-minute demo with a compliance architect — bring a real client SOP, we’ll show you the tenant model in action.