Case Study - ERP Selection to Implementation for a Radiopharmaceutical Start-Up
A new radiopharmaceutical company was building its first manufacturing and distribution network from a standing start: new cGMP facilities, a product with a half-life measured in hours, and no ERP. The company needed a system of record chosen, implemented and validated before commercial production, with a small team already stretched across construction, quality and regulatory work. John Hannan LLC ran the ERP selection in 2024 and has supported the implementation and operating build-out since.
The situation
Radiopharmaceutical therapy manufacturing is unlike almost anything an ERP vendor demonstrates by default. Materials decay on a clock, so planning, dispensing and shipping are scheduled to the hour. Production is batch-based under GMP with lot genealogy, quarantine and release. Radioactive material licensing sets limits on what can be held where. Distribution runs through specialized logistics. The company had none of the legacy systems that usually constrain a selection, but also none of the process history that usually informs one.
What we did
Requirements were built from the ground up with the leadership and functional leads, covering finance, procurement, GMP production, quality, inventory and license limits, capacity planning around radioactive decay, and distribution.
A formal RFP went to a short list of platforms and partners with credible life-sciences and process-manufacturing experience, including Epicor, IFS and Microsoft Dynamics 365 with their implementation partners. John Hannan LLC ran vendor communications so the client team could stay on its build-out.
Scripted demonstrations used the company's own scenarios: a production day, a batch record, a hold and release, a time-critical shipment.
Scorecards, debriefs and total-cost-of-ownership analysis produced a recommendation the leadership team could defend to its board.
The decision
The company chose a platform and partner combination that fit its process-manufacturing and quality requirements without forcing enterprise-scale complexity onto a start-up, and that could grow with additional sites and products.
What changed
Selection became the beginning rather than the end of the relationship. John Hannan LLC moved into an implementation and program-support role: representing the client in partner planning, keeping requirements and configuration decisions tied to the original scorecard, coordinating validation-related activities, and standing up the operating processes that the system supports. That role has continued for more than two years as the company has moved toward and through its first operations, at a fraction of the cost of a full-time program team.
The lessons from this program have become some of our most-read guidance on radiopharmaceutical ERP: how to split work between ERP and MES, how to plan capacity when the clock is the constraint, and how to track licensing limits inside the system.
If your program looks like this, talk to John about your ERP program.
