Smarthub Connect™ L5 Solution

Level 5+ Pharma Traceability Infrastructure for National Regulatory Control

SmartHub Connect™
for Marketing Authorisation Holders (MAHs)

SmartHub Connect™ is designed to make MAH compliance predictable. We standardize onboarding, validate at ingest, and issue a Validation Receipt for every submission, so your team spends less time firefighting exceptions and more time moving product.
Talk to onboarding team

Standards

first interoperability

Built on GS1 EPCIS. We accept EPCIS 1.2/2.0 (XML/JSON/JSON-LD) and normalize submissions into a canonical model for consistent validation and audit.
The MAH reality – pharmaceutical marketing authorization holder onboarding challenges for traceability compliance

The MAH reality

Most MAHs don’t struggle because they ‘don’t have EPCIS.’ They struggle because onboarding is slow, requirements are unclear, and failures become endless remediation loops.
SmartHub ConnectTM is built to change that operating reality: clear requirements, consistent validation, actionable feedback, and shared proof.

How
MAHs connect

AS2 and REST API connection for MAH pharmaceutical data submission to SmartHub Connect
Recommended production channels:

AS2 + REST API

SFTP legacy file transfer for MAH pharmaceutical supply chain compliance reporting
Supported for transitional use:

SFTP (legacy)

Web portal upload option for MAH pharmaceutical product data submission to SmartHub Connect
Supported for onboarding/tests:

Web portal upload

We guide MAHs to the fastest viable path based on technical maturity, without turning onboarding into a blocker.
Submission Flow

What happens when you submit

Step 1: Submit EPCIS

(AS2, REST API; SFTP legacy; portal upload for onboarding/tests)

Step 2: Normalize to a canonical model for consistent downstream handling

Step 3: Validate at ingest

(Schema + business validation rules)

Step 4: Receive a Validation Receipt

(Shared with the regulator)

Step 5: Fix and resubmit with clear failure reasons and a shorter remediation cycle

SmartHub Connect validation receipts workflow for MAH pharmaceutical compliance and regulatory reporting

Validation Receipts

Validation Receipts: proof you can use

Every submission generates a Validation Receipt that both MAH and regulator can reference. This ends ambiguity in audits, escalations, and disputes.
Each Validation Receipt includes:
  • Capture ID
  • Receipt timestamp
  • Dataset hash
  • Status (pass/fail + warnings)
Receipts can be exported with a complete audit pack (receipt + validation report + supporting logs).
Validation Receipts confirm submission integrity + validation outcome. They are not regulatory approval.

high level
What we validate at ingest

Validation is designed to prevent downstream chaos and reduce resubmission loops:
  • Structure and completeness: required fields and EPCIS structure present
  • Identifier integrity: format and consistency checks
  • Event logic: prevent contradictory event flows
  • Master-data alignment: submitted attributes align with program expectations
  • Duplicate and integrity controls: prevent ambiguous or duplicate submissions

Why outcomes become predictable

SmartHub ConnectTM reduces variation by normalizing all supported formats into one canonical model and enforcing the regulator’s rules consistently.
Result: fewer surprises, fewer resubmissions, shorter time-to-validation, and a clearer operational workflow for MAH teams.

Onboarding

Onboarding: what to expect

Account + access setup

Roles, permissions, technical point of contact
  • Phase 1

Connectivity setup

AS2 or API; legacy paths if needed
  • Phase 2

Test submissions

Validate, remediate, repeat until stable
  • Phase 3

Go-live readiness

Repeatable passes, predictable correction cycles
  • Phase 4

Continuous Operations

Production submissions with ongoing dashboard visibility and receipt-backed proof
  • Phase 5
Start MAH Onboarding

Support

How we support you

  • Clear onboarding requirements and submission options
  • Technical guidance for AS2/API setup
  • Actionable validation feedback paths
  • Receipt-backed audit packs for escalation and audit workflows
SmartHub Connect MAH onboarding and technical support services for pharmaceutical traceability implementation

MAH
FAQs

1. Do you accept EPCIS 1.2 and 2.0?
Yes—EPCIS 1.2/2.0 in XML/JSON/JSON-LD.
You receive clear failure reasons, remediate, and resubmit. The goal is shorter correction cycles, not ticket chaos.
No. It confirms submission integrity and validation outcome, not regulatory approval.
SFTP is supported for legacy use and transitional flows. Recommended production channels are AS2 + REST API.

Next Steps

Download

Download the MAH Onboarding Guide

01

Schedule

Schedule onboarding kickoff

02

Submit

Submit first test cycle

03

Go live

Go live with predictable, receipt-backed submissions

04

Talk to onboarding team
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