We know the process before the first meeting
We know what lies behind a deviation, a batch record, a variation or a pharmacovigilance case. You don't have to explain the process to us from scratch, and the first conversation is already technical.
We know the work from the inside, and the inspection room too
Software engineering by a team that comes from the pharmaceutical industry, not by a consultancy that discovered the sector last year.
We have worked on the client's side
Before building software for the pharmaceutical industry, we worked inside it: in pharmaceutical companies, in quality assurance, on the production floor, in regulatory affairs and in IT. We have used systems like the ones we now build, and we have been in audits and inspections when the evidence was requested.
We know what gets asked in an inspection
Who did what, when, why and with what evidence. That is why the audit trail and the electronic signature are designed in from the start, not added at the end.
We validate with a user's judgment
We know what an oversized validation costs, and what one that can't stand up to an audit costs. We match the effort to the real risk of the process, no more and no less.
How we see the work
Four things we don't negotiate.
The system is yours, and so is the code
We deliver the source code and the technical and validation documentation. If one day you decide to carry on without us, you can. A supplier that holds on to the knowledge is a regulatory risk.
We say no when we should
Some projects shouldn't be custom-built, and some requests complicate compliance without adding anything. We say so before signing, which is when it helps.
We speak the language of quality and of IT
There's no need to translate between your quality lead and your IT team. We understand what each of them needs and bring it into the same system.
We don't depend on any AI vendor
We don't resell model or platform licenses. We choose the model that suits each case and leave the system ready to switch, because the model market moves faster than a validation cycle.
When we say no
- A standard product already solves it well.
- The process isn't defined, and software would only automate the mess.
- The only goal is to “have AI”, with no clear objective.
- Validating it would cost more than the system will save.
Who we serve
We work with companies in Spain, Portugal and Latin America.
Pharmaceutical companies
With their own or contract manufacturing, inspected by European or US agencies.
Growing biotech companies
That reach the point where the spreadsheet is no longer defensible but a corporate system isn't due yet.
Contract research organizations
Clinical trial data management and sponsor systems.
Contract manufacturers
With several clients and several documentation standards side by side.
Pharmaceutical distributors and logistics
With traceability, temperature and verification obligations.
Marketing authorization holders
That manage registration and pharmacovigilance without a plant of their own.
Let's talk about your process
Tell us which process you want to solve and we'll tell you how we would approach it.