01The systems in the way
A dossier is assembled from a LIMS the vendor will not open, a document system with no API, and an archive of scanned PDFs. The authority accepts it through a web portal with strict format rules, and rejects it for reasons that are mechanical rather than scientific. Every iteration costs weeks.
| System | What it gives you |
|---|---|
| LIMS | vendor only |
| Doc management | no API |
| Trial system | partial API |
| Authority portal | web only |
| Quality | validated env |
| Archive | scanned PDF |
02Why the usual approaches stall
Generic document tooling cannot be introduced into a validated environment without qualification work that often exceeds the benefit. Anything unvalidated is unusable regardless of how well it performs.
If a human can do it in a browser or a terminal, an agent can do it — at volume, with an audit trail. That is the whole basis of how we approach pharma & life sciences: we treat the systems you already run as the integration surface, rather than waiting for an API that is never going to ship.
03What an agent actually does here
Worked example
A submission agent assembles dossiers from LIMS and document systems, checks them against the authority’s format rules before filing, and tracks the review to decision — so mechanical rejections are caught before submission rather than after.
This is a reference design drawn from the problems we are asked about most often in pharma & life sciences — not a case study of delivered client work. Where we have shipped a build, we say so plainly and put you in touch with the client.
04Constraints we design to
- Designed to operate within validated environments, with qualification documentation
- Deterministic checks are used for format rules; models are not asked to guess compliance
- Full traceability from every assembled section back to its source record
- Deployable on-premise where research data cannot leave the organisation
Tell us which system is the problem
Describe the workflow that is done by hand today and the system that blocks it. We will come back within one working day with an initial read on feasibility — including if the honest answer is that an agent is the wrong tool.
Scope your agent →