Lab to site.
Inspection-ready every mile.
One platform carries the shipment, and the proof. Part 11 e-signatures, denied-party screening, cold-chain prediction and tamper-evident custody, deployed inside your infrastructure.
Origin · Your lab, San Francisco
A compound leaves the lab.
An anti-CD20 monoclonal antibody, 25 kg, bound for Geneva on a frozen lane. The science is done. Now it has to move.
Material
Biologics, mAb
Lane
SFO → Geneva
Temperature
–20 °C, frozen
Scroll to follow the shipment
0+
API routes, OpenAPI 3.1 documented
0
test assertions on regulated paths
0
sanctions lists screened nightly
0-bit
AES-GCM encryption on every PII field
Live in hours. Not next year.
Enterprise logistics rollouts are measured in quarters and consultancy invoices. This one is a single Helm chart, and your history comes with you.
Hours
to deploy
One Helm chart into your own cluster. Your platform team approves it like any internal workload. No SaaS onboarding queue, no integration consultants.
£15k
to start
A 90-day pilot, fully creditable against year one. Not a seven-figure commitment just to find out if it fits.
Built in
migration
Validated imports from CSV, Excel, SAP and Oracle OTM, with dry-run mode, per-row error reporting and rollback. Your history arrives intact and audited.
Walk away
any time in the pilot
Not a fit? You owe nothing further. The risk sits with us, not with your budget line.
Typical enterprise rollout: 12 to 18 months
PharmaLogiks pilot: shipping in week one
Five vendors. One platform.
That journey you just scrolled? A typical mid-size biotech runs it across five tools at £330–680k a year, plus the people who assemble the audit packs by hand.
Screening, cold chain, e-signatures, tracking and clinical logistics in one record, with the audit pack generated, not assembled.
From £120k / year
50–60% below the stack it replaces
Built for the day the inspector arrives.
CREATE TRIGGER audit_no_update BEFORE UPDATE OR DELETE ON "AuditLog" EXECUTE FUNCTION block_mutation();
Append-only at the database layer
Audit, custody and e-signature tables reject UPDATE and DELETE at the PostgreSQL trigger layer. Tamper-evident even with direct database access, not just application-level promises.
integrityHash = sha256( shipmentId | userId | meaning | isoTimestamp )
Record-state signature binding
Every e-signature cryptographically binds to the exact record state at the moment of signing (§11.200(b)). Edit anything afterwards and verification flags the mismatch.
IQ ▸ schema v68 · triggers verified OQ ▸ 2,449 assertions · e-sig integrity PQ ▸ 30-day KPIs · DPS coverage
IQ/OQ/PQ generated per deploy
Each deployment renders a structured validation report against the running system, real evidence for your CSV programme, not vendor self-certification.
Officers review the shipment.
The system enforces the rest.
Material classification, document completeness, denied-party screening and export-control checks run as gates, a shipment physically cannot reach approval with a missing document or an unscreened consignee. Overrides require a reason and land in the audit trail.
- Corridor rules block submission until required documents exist
- Server-enforced state machine, terminal states are immutable
- Dual-officer approval mode for high-risk corridors
AI that fixes the inputs.
Scientists are brilliant at science and famously not at customs paperwork. The platform closes that gap before it costs you a border hold.
Lab language in. Customs language out.
What the scientist writes
“frozen antibody samples for the Geneva trial”
What the platform drafts
Officer approvesHS 3002.15 · Immunological products, monoclonal antibodies, frozen, clinical investigation use
Customs descriptions and HS codes drafted from the material record by local AI, reviewed by a human, and risk-scored 1 to 10 with a plain-English reason. Cleaner data means faster clearance and fewer queries at the border.
Consolidation the desk can see.
The platform notices
Two shipments, same lane, same week, compatible pack-outs
It suggests
Freight savedOne booking, one validated shared pack-out, and a carrier swap where the scorecard says so
Routing consolidations, carrier swaps and cold-chain efficiency suggestions surface at the shipping desk automatically. Real freight money, found by software instead of spreadsheets.
Connected in. Connected out.
Single-tenant does not mean siloed. Data flows in from the systems you already run, and out to every role that needs it, with every query audited.
Integrations that pull their weight.
Sites and protocols sync from your CTMS. Approved freight spend flows to your ERP. Carriers quote and track natively. BI tools query a governed feed instead of exported CSVs.
Reporting that ships with the platform.
Native and role-tailored by default, not a data-extraction project bolted on in year two. The same records that carry the signatures feed every view.
Point tools see a slice. We hold the record.
| Capability | PharmaLogiks | E2open | Veeva | Sensitech |
|---|---|---|---|---|
| Pharma-native workflows | ||||
| On-prem / air-gap deployment | ||||
| Part 11 record-state e-signatures | ||||
| DB-enforced custody immutability | ||||
| Cold-chain early-warning | ||||
| TAET stability budgets | ||||
| Typical annual cost | From £120k, full platform | £80–120k / yr (screening scope only) | £80–160k / yr (document scope) | £30–60k / yr (monitoring only) |
The record that proves it pays for it.
Every shipment touches a scientist, a compliance officer, and a freight invoice. One platform takes time and waste out of all three. Move the sliders to your operation.
Your numbers
Scientist input time
Setup drops from an hour to five minutes per shipment
Compliance review time
Automated gates cut review time, about 15 minutes a shipment
Denied-party screening in-house
No per-query metering or year-end overage bills
Invoice reconciliation
Freight billing errors and double charges caught before payment
Fewer rejected shipments
AI customs descriptions cut border rejections and rework
Package consolidation
AI finds consolidations and carrier swaps
Estimated annual saving
£267,000
£134 per shipment
Scientist time returned
1,833 hrs
about 1 full-time scientist, back on the science
Estimates from your inputs and conservative defaults: 15 minutes of compliance review saved, 3% recovered from freight-invoice errors, a 4% baseline rejection rate cut by 60% at £250 a rejection, and 6% from consolidation. Your figures, not ours.
Direct impact to science
Hours off the customs form. Hours back on discovery.
The scarcest resource in drug development is qualified scientist time. At 2,000 shipments a year, the platform hands back 1,833 scientist-hours, the equivalent of about 1 researcher focused full-time on the science instead of the paperwork.
≈1
scientists, full-time on research
The hidden meter
Denied-party screening that does not bill you by the query.
Metered screening charges per query, with an allowance you quietly pass at one screen per shipment. The overage shows up as a surprise at year-end, and at volume it runs into five figures. PharmaLogiks screens in-house, on every shipment, with no meter and no allowance.
£0
per query, ever
Priced to displace, not to stack.
Pilot
£15k 90 days
One programme, one site, white-glove install. Fully creditable against year one. Walk away if it isn’t a fit.
CTM Starter
£120–150k per year
All core modules, on-prem deployment included, up to 5,000 shipments, 99.5% SLA. For 1–2 active programmes.
Enterprise
£600k+ per year
Unlimited volume, custom modules and corridor rules, named TAM, co-developed roadmap, £5M indemnity.
The questions your QA team will ask.
Yes, single-tenant by design, not a retrofitted SaaS. It ships as a Helm chart that deploys into your own Kubernetes cluster, on your storage and your network policy. Air-gapped installs make zero outbound calls: fonts are self-hosted, API docs are vendored locally, and all AI inference runs on Ollama inside the cluster.
See it live in 25 minutes.
Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.