For Marketing Authorization Holders (MAHs)

One serialization platform. Every CMO. Every market.

Marketing Authorization Holders carry the FMD responsibility — but the codes are printed wherever the product is made.

SecIdent Pharma orchestrates serialization across all your contract manufacturers, pushes verified data to the EU Hub, and gives you a single audit-ready view of every batch, every serial, every market. No CMO migration required. No gaps between sites. No surprises during inspection.

FMD-compliant · EU Hub connected · ISO 27001 certified · Built and operated in the EU

Isometric illustration of a central control room connected by glowing amber data lines to five pharmaceutical production sites arranged around it, symbolizing orchestrated serialization across multiple contract manufacturers.

Where MAHs lose sleep

The responsibility is yours. The complexity isn't always under your control.

  • EU Hub integration Connecting to the EMVS European Hub is technically demanding and unforgiving. One malformed message, one missed acknowledgement, and your reportable serials are out of sync with the regulator.

  • Inspection exposure A serialization audit doesn't go well or badly — it goes well, or it threatens market access. Incomplete validation evidence is the single fastest way to turn a routine inspection into a finding.

  • CMO fragmentation Every contract manufacturer runs a different L3 stack, different file formats, different upload rhythms. Reconciling all of it into one defensible data set is a full-time job.

What you get with SecIdent Pharma

One platform between you, your CMOs, and the regulator.

  • Gateway to the EU Hub BrainGate is our validated, productive connector to the EMVS European Hub. Messages, acknowledgements, retries, reconciliations — handled inside SecIdent, not in a spreadsheet.

  • Validation evidence on release day Every SecIdent Pharma release ships with complete validation documentation. When the inspector asks, you hand over a binder, not an excuse.

  • Centralized control:

    • Serial numbers, batches, and product data are managed centrally

    • Multiple contract manufacturers (CMOs) with different systems and processes are coordinated in SecIdent

    • Guaranteed full transparency across all serialization activities

Übersicht wie SecIdent Pharma bei MAHs genutzt wird

Get in Touch!

Contact Us & Request a Quote

As part of a free and non-binding initial consultation, we will discuss how you can implement your serialization requirements with SecIdent. We are happy to demonstrate the system and answer any questions you may have

Your company situation

If you tell us a bit about your company and current processes, we can address your situation more specifically.

Your contact details

Considering Switching Your Provider?

Benefit from Years of Expertise.

Changing systems may sound complicated and time-consuming, often raising concerns about disruptions or “friction losses.” We understand these concerns and are fully aware of the challenges such a transition can bring.

Our experienced experts have successfully replaced existing systems multiple times and will support you personally from the very beginning. Whether it is a full cutover or a gradual transition with parallel operation, we ensure that you, your employees, and your partners remain fully operational at all times—and that the benefits of SecIdent become noticeable as quickly as possible.

Your partners—whether CMOs or MAHs—typically do not even notice the transition. SecIdent seamlessly continues to support existing interfaces, including integrations with TraceLink, Arvato, SAP, and many others.

Collaboration with partners who already use SecIdent benefits even further through the elimination of interfaces altogether. In addition, this opens up numerous improvements, such as granular permissions, detailed audit trails, and the immediate release of batches and serial numbers

BRAINORITY Software GmbH
Vor dem Lauch 15
70567 Stuttgart
Germany