Research and development
Electronic lab notebook, pilot batch tracking, design of experiments and technology transfer to the plant with the decision history intact, which is what nobody can find three years later.
R&DYour process doesn't adapt to the software. The software adapts to your process
We don't sell licenses. Every project starts by looking at how the work gets done today, and at how much of that work is fighting the current tool or making up for it with a spreadsheet nobody has validated.
Across the life of a medicine
From molecule to patient.
Top, the life of the medicine; bottom, the processes that run across the company.
- Research and developmentR&Dlab notebook and pilot batches
- Clinical trialsGCPdata that mirrors the protocol
- RegistrationRegulatoryauthorization by country
- ManufacturingGMPelectronic batch recordtechnology transfer to the plant
- Quality controlGLPsamples, tests and stabilityout of specification: investigation
- DistributionGDPserialization and temperature
- Patienttraceable to the point of dispensing
- Quality systemGMPdeviations, changes and CAPA
- PharmacovigilanceGVPcases, deadlines and signals
- Documents and trainingGxPcurrent version and training
- Internal operationsSupportpurchasing, maintenance
Clinical trials
Data capture that mirrors the protocol, reconciliation against the central lab and pharmacovigilance, deviation tracking by site, and datasets traceable back to the source data.
GCPRegistration and regulatory affairs
The lifecycle of each authorization by country, variations and their status, post-authorization commitments with their deadlines, and a warning before something expires, not after.
RegulatoryManufacturing
Electronic batch record with guided execution, direct reading of instrumentation, material reconciliation and review by exception: looking at what went out of range instead of reading a hundred pages.
GMPQuality control
Sample and test management, a stability program with its time points and alerts, out-of-specification results with the associated investigation, and connection to laboratory instruments.
GLPDistribution and supply chain
Serialization and verification, traceability down to the point of dispensing, temperature logging in transport and incident management with the wholesaler under Good Distribution Practice.
GDPAnd in the processes that run across the company
Quality system
Deviations, change control, CAPA, internal audits and supplier qualification, with impact assessment and effectiveness checks where they apply. Overdue actions show up before an inspector sees them.
GMPPharmacovigilance
Case intake through any channel, reporting deadline control, signal tracking and preparation of periodic safety reports. The compliance clock starts at receipt, and the system keeps count for you.
GVPDocuments and training
Current version, recorded reading and a training matrix by role, so that nobody runs a procedure they haven't read and the evidence exists on the day it is requested.
GxPInternal operations
Purchasing, assets, maintenance, calibration, incident management. Processes that aren't always regulated but support the ones that are, and that tend to be the worst served by existing software.
SupportYou don't always need a new system
Integrate and extend before replacing.
Connect what already exists
Bridges to your ERP, your laboratory system and your document management system, with full traceability of every piece of data that crosses the boundary between two systems, which is exactly where integrity gets lost.
Stabilize legacy systems
Systems that work but can no longer be sustained: no vendor support, no documentation, or a validation that expired several versions ago. What you have gets stabilized before anyone proposes replacing it.
Add AI to your platform
If you already work with a quality, safety or manufacturing platform, the AI you need can live in a component of its own connected to it, without waiting for the vendor to put it on their roadmap.
SAP
LIMS
DMS
MES
EBR
WMS
CMMS
CRM
Integration
We can also host and maintain the system for you
If your team can't or would rather not.
The usual approach is to install the system in your cloud or on your servers and have your IT team run it. If you don't have the capacity to do that, or would rather not take it on, we host and maintain it ourselves on Microsoft Azure or Amazon Web Services, in the region your regulations require, within the European Union or in Latin America.
- Qualification of the infrastructure, which is part of the validated system
- Documented assessment of the cloud provider
- Backups and service continuity
- Monitoring and updates under change control
- The code, the data and the documentation remain yours, and you can move the system to your own infrastructure whenever you want
Regions in Spain (Madrid) and other EU countries, Brazil, Mexico and Chile.
Regions in Spain and other EU countries, Brazil (São Paulo) and Mexico.
Regions checked against each provider's official lists in October 2026. Trademarks belong to their owners.
Where AI adds value and where it doesn't
With human oversight and model traceability.
Artificial intelligence handles well the reading and classification work that today eats up hours of qualified staff: checking a procedure against an updated standard, grouping deviations that describe the same problem in different words, proposing the coding of an adverse event, finding which dossier holds the answer the agency is asking for.
It doesn't make the decision. A batch is not released by a model; it is released by a Qualified Person who answers for it. We build systems so that what the model proposed, with which version, and what the person decided are all on record.
The model prepares the documentation. The signature still belongs to the person who answers for it.
Which process is costing you the most?
We'll propose the system that would solve it, with the level of control it calls for.