Life sciences software built for scientists and auditors alike
We build software for pharmaceutical companies, biotech start-ups, contract research organisations and laboratories. Data integrity and traceability matter as much as the science the software supports.
What gets in the way
- Lab and research data is spread across instruments, spreadsheets and notebooks, making it hard to find and reuse.
- Regulated systems need audit trails, electronic signatures and validation evidence that generic tools lack.
- Clinical trials depend on patient-facing apps and data capture that must be reliable and secure.
- Teams want to apply AI to research data but need traceable, reproducible results.
Built with the rules in mind
Life sciences software is shaped by GxP expectations, electronic records rules, clinical trial regulation and health data protection law. We build with these in mind, produce documentation that supports your validation, and work with your quality and regulatory teams, who remain responsible for sign-off.
Technologies we often use
How we help in your market
The rules, platforms and buyer expectations differ by region. We design for the one you sell into.
Europe & UK
UK and EU teams work with the MHRA and EMA, EU GMP Annex 11 for computerised systems, the EU Clinical Trials Regulation and the GDPR for health data. We build audit trails, electronic signatures and data integrity controls in line with ALCOA+ principles, and provide traceable test evidence for your validation.
United States
US teams must meet FDA 21 CFR Part 11 for electronic records and signatures, GxP expectations and, where patient data is involved, HIPAA. We build Part 11-aware controls such as audit trails, signature manifestation and access control, and follow a risk-based approach your QA team can validate.
Canada
Canadian companies work with Health Canada, its GMP guidance and clinical trial regulations, alongside PIPEDA, Quebec Law 25 and provincial health privacy laws. We build data integrity and consent controls, and bilingual English and French patient materials where needed.
What we build for pharma
Lab data platforms
Capture and structuring of instrument and experiment data for search and reuse.
Quality management tools
Deviations, CAPA, change control and document control with e-signatures.
Clinical trial apps
Patient apps for eConsent, diaries and reported outcomes, and site tools.
Integrations with LIMS and ELN
Connections between lab systems, instruments and analytics.
AI for research and documents
Literature search, document drafting support and data analysis with review.
Validation support
Traceable requirements, test evidence and release records for your QA team.
How we help
Custom Software Development
Bespoke business systems built around how your organisation actually works, not how an off-the-shelf package assumes it does.
Mobile App Development
iOS and Android apps, native or cross-platform, published under your own App Store and Google Play accounts.
AI & Machine Learning
Practical AI: LLM features, agents, document extraction and predictive models, built with your data privacy in mind.
API & Systems Integration
APIs and integrations that connect your CRM, ERP, payments and internal systems so data moves without manual re-keying.
Data Engineering & Analytics
Data pipelines, warehouses and dashboards that turn scattered business data into reliable numbers people trust.
QA & Software Testing
Manual and automated testing, performance and security checks so releases reach users without unwelcome surprises.
Common questions
How much does custom pharma software cost to develop?
We quote from a written requirements document. Regulated systems need extra work on documentation and testing, so we include that in scope rather than adding it later.
Is your software 21 CFR Part 11 compliant?
Compliance depends on how the system is configured, validated and used, so we do not claim it for you. We build Part 11-aware controls and provide evidence your QA team can use in validation.
Can you support computer system validation?
Yes. We provide traceable requirements, risk assessments, test scripts and results, and release records that fit into your validation approach under your QA team's direction.
Can you integrate with our LIMS, ELN or instruments?
Yes, where those systems expose APIs, file exports or standard formats. We review interfaces early and build reliable, logged data transfers.
Can you build patient apps for clinical trials?
Yes. We build iOS and Android apps for eConsent, diaries and patient-reported outcomes, with offline support and secure sync.
How do you use AI in regulated life sciences work?
We use AI where outputs can be reviewed, such as literature search or drafting support, and record model versions and prompts so results can be traced.
Can you work with GAMP 5 principles?
Yes. We follow a risk-based approach consistent with GAMP 5 thinking, and adjust the depth of testing and documentation to the risk of each function.
Where is our research data hosted?
In a cloud account in your name, in the regions you choose, with access limited to named people and all access logged.
Can you protect our intellectual property?
Yes. We sign an NDA on request, you own all code and repositories, and we work within your systems and access rules.
Can you build a data platform for our research teams?
Yes. We build pipelines that bring instrument, assay and study data together into a searchable, well-governed platform for analysis.
More sectors we serve
Have a project in mind? Let’s talk.
Tell us what you are building. We reply within one business day with next steps — and we are happy to sign an NDA first.