Enterprise

For pharma and CDMO organizations with regulatory responsibility, internal champions, and procurement processes that demand more than a self-serve subscription.

What Enterprise Includes

• Single-tenant hosting on dedicated Hetzner hardware in Leipzig. No multi-tenant noisy-neighbor, no US CLOUD Act exposure.
• SLA with penalties — typically 99.9% availability, response times defined by severity, with concrete service credit on miss.
• GxP validation pack — prepared URS, FS, risk assessment matrix, IQ/OQ/PQ templates for GAMP 5 Software Category 4. Reduces validation effort from 4–8 weeks to 1–2 weeks.
• On-prem deployment option — container image for Kubernetes, Helm chart, or classic Docker Compose. Air-gap capable.
• Custom integrations — connection to internal ELN, LIMS, lab software, or proprietary databases.
• Custom tools — if your workflow needs a tool we don't have yet, we build it. Stays as a CovaSyn component, but with co-development IP clarification.
• Dedicated customer success engineer — one person who knows your stack, monthly reviews, on-demand support.

Champion Kit

If you advocate for CovaSyn internally, these are the building blocks you need:

1-Pager argumentation for management

"We lose 80–200 hours of med-chem time per month to manual ICH M7 triage, stability evaluations, and impurity profiling. CovaSyn replaces this work with deterministic, validated MCP tools with audit trail. Pro subscription costs €250/month — ROI for a 5-person team is typically 5×, for a CDMO with quote pipeline 100×+. Enterprise with validation pack additionally reduces GxP validation effort for any submission-relevant workflow."

ROI example (CDMO with 30 quote requests/month)

Cutting time-to-quote from 5–10 days to 1–3 days means 4–8 additional quotes per month. At 30% win rate and €80–150K margin per contract: €1.2–3.7M additional annual revenue. Enterprise cost typically €30–80K/year → ROI 15–120×.

Risk-mitigation talking points

• Vendor stability: CovaSyn GmbH (Leipzig, HRB 43655). Operating since 2024, commercially self-funded, no VC term-sheet risks forcing pivots.
• Data exit: All data stays in your tenant. At contract end: complete export of your audit logs within 30 days, no vendor lock-in.
• Source-code escrow: Available in Enterprise tier. If CovaSyn exits the business, you receive access to source code for continuity.
• Insurance coverage: E&O (Errors & Omissions) and cyber insurance in place, certificates on request.

Vendor lock-in answer

CovaSyn uses the standardized MCP protocol. Your workflow scripts, agent prompts, and client configurations work with any MCP-compliant server. Migration to another stack (commercial or open source) is a 1–3-day engineering project, not a multi-month migration pain.

Procurement Pack

What we provide on request before you sign anything:

• DPA — standard data processing agreement per Art. 28 GDPR, adaptable to your compliance requirements.
• Security questionnaire — pre-filled answers to typical pharma vendor risk assessment questions (CAIQ, SIG-Lite compatible).
• GAMP 5 Cat 4 argumentation — formal justification why CovaSyn is classified as Configured Product, with derivations for validation scope reduction.
• DACH data residency proof — Hetzner hosting attestation, subprocessor list, third-country transfer documentation (for sites without third-country transfer: none).
• Insurance certificates — E&O and cyber insurance certificates from the insurer.
• Pen-test report — most recent independent penetration test, severity triage, remediation status.

Onboarding Process

Four weeks from contract signing to production go-live:

1. Week 1: Kickoff with your QA lead, IT-sec, med-chem lead. Single-tenant provisioning on dedicated Hetzner node. SSO integration tested.
2. Week 2: Validation pack walkthrough with your QA. URS adaptation to your internal QMS. Risk assessment workshop.
3. Week 3: User acceptance testing with real workflows. Audit trail review. Performance validation.
4. Week 4: Production sign-off. Onboarding documentation handed over. First quarterly review scheduled.

Pricing

Enterprise pricing is contact-based — no fixed tariff, because configuration (single-tenant vs shared pool, on-prem vs cloud, custom tools, SLA severity levels, validation pack scope) varies significantly. Typical range: €30,000–80,000 per year for mid-sized pharma/CDMO sites. All Enterprise contracts include Pro-tier subscription equivalence for unlimited users.