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.

PL-394650
Draft

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

21 CFR Part 11EU GDPGDPR Art. 17 & 20EMA Annex 11ICH Q1A(R2)ICH Q5COFAC · BIS · EU · UN · OFSIIQ / OQ / PQECCN / EARCITESIATA DGFHIR R4

0+

API routes, OpenAPI 3.1 documented

0

test assertions on regulated paths

0

sanctions lists screened nightly

0h

cold-chain breach forecast horizon

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.

Denied-party screeningE2open / Amber Road
Cold-chain monitoringSensitech portal
E-signatures & doc controlVeeva / DocuSign
Shipment trackingproject44
Clinical courier portalMarken
PharmaLogiks Enterprise

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.

The real product

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

See the full feature tour →

PharmaLogiks compliance review workspace showing material review, document review and compliance checks for a frozen biologics shipment

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 approves

HS 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 saved

One 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.

CTMSVeeva VaultMedidata RaveOracle CTMSFHIR R4
ERP & financeSAPOracleSageXeroQuickBooks
CarriersDHLFedExUPSWorld CourierMarkenDPDTNT
BIPower BITableauOData feed, per-consumer audit

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.

ComplianceApproval rates, time-to-approve, DPS clear rates, doc-gate blocks
Shipping deskLive queues, carrier scorecards, SLA breaches, lane performance
LeadershipSpend, volumes, trends and chargebacks by division and project
AuditEvidence packs and APR transport chapters, generated in one export

Point tools see a slice. We hold the record.

CapabilityPharmaLogiksE2openVeevaSensitech
Pharma-native workflows
On-prem / air-gap deployment
Part 11 record-state e-signatures
DB-enforced custody immutability
Cold-chain breach prediction
TAET stability budgets
Typical annual costFrom £120k, full platform£80–120k / yr (screening scope only)£80–160k / yr (document scope)£30–60k / yr (monitoring only)

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.