Most use cases do not survive. Find out in an hour.
Six specialists interrogate the idea, price it, architect it and rule on compliance — then hand you a pack you can defend.
A widget is a tool; an agent is someone who decides. Any of them can stop the engagement, and Agent 05 is designed to.
Attacks the idea six ways and rules each attack survived, wounded or fatal.
Prices it as a range with a payback month. Never headcount.
Maps source to destination, names the gaps, and says what happens when the model is wrong.
Team shape, work packages, ranked backlog, phase plan, and who decides what.
Computes a gate verdict from the answers. It can stop the engagement.
Sweeps every claim for a source before the pack is allowed out.
One versioned pack. The Evidence and QA Reviewer sweeps it for unsourced claims first, and can refuse to release it.
Four systems that ran in production inside Johnson & Johnson, Boehringer Ingelheim, Gilead, Novo Nordisk, Sanofi and Chiesi.
Seven stages in the order a molecule travels. Quality and engineering are not stages — they run underneath all seven.
Every regulatory position states the date it was current.
Bounded nondeterminism, guardrail qualification, abstention thresholds and revalidation triggers, a complete test strategy for generative systems inside regulated pharmaceutical processes.
17 min readOne organisation in fifty-nine is ready; the variable predicting regulatory operations performance is accountability for data, not artificial intelligence. today
13 min readPfizer struggled two decades with electronic batch records; costs per site fell eighty percent once leadership changed, not the software.
13 min readMost do not survive the bench. An hour here is the cheapest place to find that out. Tareef Roustom built it.
