Pharmaceutical
Drug development timelines, clinical trial data, and manufacturing quality controls sit in systems that rarely talk to each other. We build the data integration, analytics, and compliance reporting layer that gives R&D, manufacturing, and regulatory teams a coherent picture without sacrificing the auditability that FDA and EMA review demands.
What we get right in pharmaceutical.
Clinical and trial data platforms
Aggregate trial, lab, and patient data from disparate sources into a governed analytics layer. Faster signal detection; full lineage for submission packages.
Regulatory compliance reporting
Reporting and audit platforms built to FDA 21 CFR Part 11 and GxP principles, with data lineage and access controls that hold up during inspections.
Supply chain and batch traceability
End-to-end traceability from raw material to patient. Deviation tracking, batch analytics, and supplier-quality dashboards that reduce recall risk and speed corrective action.
What we get asked to build.
- Clinical trial data integration and analytics
- Regulatory submission data management
- Batch traceability and quality reporting
- Pharmacovigilance and signal detection platforms
- GxP-validated computer system deployment on Azure
- Cold chain monitoring and deviation reporting analytics
- LIMS and EDC data integration into a unified analytics platform
- Manufacturing deviation and CAPA tracking dashboards
What we bring to pharmaceutical.
Regulatory data architecture
FDA 21 CFR Part 11, GxP, and eCTD submission requirements mean pharmaceutical data needs electronic records with audit trails and controlled access. We build those controls into the platform architecture, not as an overlay.
Clinical data integration experience
EDC systems, LIMS, PK/PD models, and clinical trial management systems each produce data in different formats at different cadences. We have built the integration and harmonization pipelines that make cross-system analysis possible.
Validation-ready delivery
Computer system validation requirements in GxP environments mean every system change needs documented evidence. We design for validation readiness: test protocols, change control, and traceability matrices built into the delivery process.
Supply chain and batch traceability
Drug substance to finished product traceability, cold chain monitoring, and batch release analytics that reduce recall risk and accelerate quality investigations, built on the data that already exists in your manufacturing systems.
What clients typically see.
Doing similar work in pharmaceutical?
Tell us what you are trying to change. We will either be useful, or point you to who would be.