The situation
A pharmaceutical manufacturer's serialisation obligations do not stop atits own production gates. When products are packaged by contract partners, the commissioning data generated on those lines must flow correctly into the brand owner's environment and, from there, into the EU Hub. Under EU FMD there is no regulatory distinction between a pack serialised in-house and one serialised bya CMO. Both have to be accounted for, and both have to be right.
For a European life sciences manufacturer building its own independentTraceLink infrastructure, this created a parallel workstream that could not wait for the internal rollout to finish. Each contract manufacturer needed to be connected to the new environment. None of them ran the same serialisation system. And there was no established process for doing any of it.
The client had CMOs, a platform and a timeline. How to connect one tothe other, across several external partners with different technical setups, different internal priorities and varying levels of serialisation experience,was a question nobody had answered before. The client engaged Amalia to build the answer and deliver it.
What was at stake
Every product line manufactured by a CMO depended on a live, functioning connection between that partner's serialisation system and the client'sTraceLink environment. Without it, commissioning data could not be uploaded to the EU Hub, or would require manual processes that introduced risk and could not scale. A supply chain held together by undocumented, bespoke integrations understood only by the people who built them accumulates compliance exposure quietly, until something changes and nobody knows how to fix it.
There was also a longer-term question. CMO networks are not static.Manufacturers get added. Products move between sites. Partners are replaced. An onboarding process that had to be reinvented each time the supply chain shifted was not a solution. It was the same problem appearing repeatedly under different circumstances.
What the engagement needed to be
Getting the existing CMO network connected was the immediate requirement. Building something the client could extend and operate without external support was the real deliverable.
That distinction changed the scope considerably. A purely technical approach, treating each CMO as a separate integration project, would have produced a set of live connections with no transferable process behind them.What was needed was a methodology: a defined, documented sequence that any future CMO could be walked through, with the clarity and completeness to sit on a shelf and be used by an internal team without the original project members in the room.
Amalia designed that methodology. Not as a byproduct of the technical work, but as a deliberate first output of the engagement. Every stage of the partner journey was mapped and formalised before the first CMO was contacted for technical scoping. The framework was built to be repeatable by design, not adapted into repeatability after the fact.
Delivering this alongside the technical work required a combination that is harder than it sounds: technical consultants with enough breadth across heterogeneous serialisation systems to configure connections that varied meaningfully from one partner to the next; project managers with the capacity to run multiple external partner relationships simultaneously without losing momentum in any one of them; and the compliance discipline to turn individual configurations into a reusable, documented framework rather than a set of one-off solutions.
Amalia provided all three from a single team. No separate compliance stream waiting on technical outputs. No project manager coordinating between suppliers who do not share context. The technical consultant, the compliance specialist and the project manager worked the same programme from the same direction, which is the only structure that makes a compressed timeline achievable. In fewer weeks than a fragmented approach would take to align on scope, Amalia had the methodology designed and the first CMOs already scoping.
The approach
Before any technical work began, Amalia ran a structured information-gathering phase across the full CMO cohort. Every partner was contacted early to establish the technical baseline: what serialisation system they ran, how their interfaces were architected, what their test environment looked like and who the right contacts were on their side. Gathering this information upfront rather than at the start of each individual onboarding served a specific purpose. It gave Amalia the complete picture of the programme before any configuration work started, which made it possible to plan and sequence multiple onboardings in parallel rather than working through them one at a time.
Running the cohort as a controlled parallel programme rather than as a sequence of individual projects compressed the overall timeline. While one CMO was in testing, another was in configuration and a third was completing interface scoping. Dependencies between partners were visible and managed at programme level. Slippage at one site could be absorbed without the whole programme shifting. This is not how CMO onboarding typically gets managed. Most organisations work through partners one at a time, or run into coordination failures when they try to run several simultaneously without the programme infrastructure to support it. Amalia built that infrastructure before the work began, which is why the parallel approach held.
Alongside the programme management, Amalia acted as the primary external contact for every CMO in scope. Not as a relay between the partner and the client's internal team, but as the team managing the relationship directly.Technical scoping, interface specification, testing coordination, issue resolution and cutover scheduling all sat with Amalia. The client's internal teams were engaged where decisions required their input, but the operational weight of keeping several external partner relationships moving at once fell onAmalia's project managers.
That structure matters in practice. CMO onboarding stalls when partners lack a single clear point of contact, when questions take time to reach the right person or when problems require escalation before they get resolved.Amalia's consultants had direct technical knowledge and direct relationship ownership. Questions were answered and issues were closed without routing anything through an internal chain. The pace of the programme reflected that.
The technical work varied considerably between partners. One CMO was already running TraceLink, which made the connection a TraceLink-to-TraceLink integration with its own configuration logic. The others ran different serialisation systems entirely, each with its own interface architecture,message formats and test environment. A configuration approach that worked at one site required a different treatment at the next, and the difference between a same-platform and cross-platform integration is not trivial. For each partner, Amalia mapped the interface requirements through direct engagement with the CMO's technical team, built and tested the configuration in the client's environment, resolved exceptions as they came up and managed cutover once testing was complete and sign-off was in hand.
Alongside the technical work, Amalia produced the process documentation the client needed to own and run the onboarding framework going forward. TheSOP for the onboarding process was written for the client's internal team,giving them a clear basis for managing future CMOs independently. Interface specifications for each connection were documented as they were built. The intent from the start was that the client would finish the engagement with a working programme and the means to run it themselves.
The outcome
All contract manufacturers were connected and reporting live within the project timeline. Serialisation coverage for CMO-produced products was operational across the EU without a gap.
The client received more than working integrations. They received a formally handed-over onboarding process and the interface specifications for every connected CMO. When the next CMO needs to be added, the process is already there. The first cohort built it and proved it.
What this illustrates
CMO onboarding is often scoped as a technical task. The technical dimension is real, and it varies more between partners than most project plans account for. But the partner management side is just as demanding and just as consequential. Keeping external organisations engaged and moving through a process that is not their primary concern requires consistent, knowledgeable contact. When that contact is fragmented across internal teams, or when the people managing the relationships do not also understand the technical detail, queries pile up, and timelines slip.
Organisations that try to run CMO onboarding through their internal serialisation function often find it becoming an unplanned helpdesk: absorbingCMO queries, chasing test cycles, and fielding the same questions across multiple partners. That overhead is manageable for one CMO. Across five or six running simultaneously, it displaces other work.
Amalia absorbed that overhead entirely, while simultaneously designing the methodology, running the technical integrations and managing the programme. That is what the engagement delivered: not just connected CMOs and a handed-over process, but a demonstration that all three can be done together ,faster, by a team that does not need to be coordinated because it already is.
A connected CMO network that the client cannot maintain independently isa dependency, not a deliverable. A documented process that nobody has run yetis untested. Getting both from a single engagement, on a compressed timeline,is what Amalia is built to deliver.
If your organisation works with contract manufacturers and needs to connect them to your serialisation environment, Amalia's TraceLink practice manages the technical integration and the partner relationship within a single engagement. Learn more about Amalia's TraceLink services and Partner Onboarding and Offboarding.
