Life sciences,
engineered end to bench.
Clinical trials, lab informatics, GxP manufacturing, quality and AI-native discovery, engineered with the regulatory rigour the sector demands, and the delivery velocity the science actually needs.
The territory, in four numbers we hold ourselves to.
Life sciences pays back what it can validate. These are the numbers our engineering practice designs against.
- GxP
- By design
- 21 CFR Part 11
- Compliant
- 30–50%
- Cycle time cut
- 6–10
- Weeks
GLP, GCP and GMP evidence trails engineered into delivery
And EU Annex 11 aligned, audit-ready evidence, not paperwork
Typical uplift on validated systems we modernise
To first validated slice in production
The life-sciences formats we build for.
Life sciences spans a family of regulated operating models. We tailor architecture, validation posture and delivery cadence to the specific rhythm and constraints of the organisation.
Pharma & biotech R&D
Discovery, translational and clinical development, with informatics, data science and AI applied through the regulated pipeline.
Clinical operations
CTMS, EDC, eTMF, e-consent and site management engineered against real trial reality, not vendor demo flow.
GxP manufacturing
MES, LIMS, e-batch, deviation, quality and regulatory reporting on validated platforms.
Medical devices
Product engineering, firmware, connected devices, SaMD and post-market surveillance, with IEC 62304 rigour.
CDMOs & CROs
Multi-tenant regulated operations with segregation, tech-transfer, e-batch review and customer-facing reporting.
Commercial & medical affairs
HCP engagement, patient support, real-world evidence and omnichannel, engineered with privacy and consent at the centre.
Services we deliver into life sciences.
Every life-sciences engagement blends R&D informatics, GxP-regulated systems and modern engineering. These are the practices we most commonly deploy into pharma, biotech, medical devices and CDMOs, each linked to its dedicated practice page.
The R&D-and-regulated estate we engineer end to end.
The life-sciences organisations that pull ahead treat R&D, clinical, manufacturing, quality and commercial estates as one connected system, governed by the same validation and audit spine.
- 01R&D & scientific informatics
- ELN, LIMS, scientific data lakes and analytics that let scientists work at the pace of the science, with FAIR data principles as the substrate.
- 02Clinical operations platform
- CTMS, EDC, eTMF, e-consent, ePRO and site-collaboration, integrated around real trial workflows and validated end to end.
- 03GxP manufacturing & quality
- MES, e-batch, deviations, CAPA, LIMS and quality analytics on validated infrastructure, with 21 CFR Part 11 and Annex 11 alignment.
- 04Regulatory & submissions
- RIM, submission planning, structured content and regulatory intelligence, with the audit trail engineered into every artefact.
- 05Commercial & patient engagement
- HCP CRM, patient support, market access and omnichannel, with consent, privacy and validation designed in from day one.
- 06Validation, security & compliance
- Computer software assurance, validated CI/CD, segregation-of-duties and cyber controls aligned to sector regimes, designed as engineering, not paperwork.
Trusted by scientists, clinical operators and quality teams.
A representative sample of the pharma, biotech, medical-device and CDMO organisations we've engineered with.
Programmes delivered in this sector.
What clients ask us first
01How do you approach GxP validation as engineering?
Through Computer Software Assurance (CSA) as the modern spine, risk-based, evidence-first, and integrated with CI/CD. Requirements, test evidence, deviation and change control live in the same version-controlled surfaces engineers already work with. Auditors get the evidence trail as an artefact of delivery, not as a reconstruction before inspection.
02Where does AI genuinely earn its place in life sciences?
In target discovery and biomarker analysis where the data supports it, in imaging AI for pathology and radiology, in medical writing and regulatory drafting grounded in your validated corpus, in pharmacovigilance triage, and in lab-assistant copilots. In every case we engineer evaluation, guardrails and human-in-the-loop against the specific blast radius, regulated environments never ship AI without evidence.
03How do you handle 21 CFR Part 11 and EU Annex 11?
As engineering primitives, not documentation. Electronic records, audit trails, e-signatures, access controls, backup and validation are designed into the platform. Evidence is generated by delivery. Alignment with FDA CSA guidance and EU Annex 11 is built into how the systems ship and change, so audits become reports against existing evidence.
04How do you approach data standards like CDISC, IDMP and FHIR?
As first-class engineering. CDISC SDTM and ADaM for clinical data submissions, IDMP for product-identification data, HL7 FHIR for interoperability with clinical systems, and OMOP for real-world evidence. Standards are how the industry compounds, we treat them accordingly.
05How do you modernise validated systems without invalidating them?
As rolling, evidence-first waves. Change control and impact assessment go first. Modernisation happens on validated infrastructure with test evidence generated continuously. Cutovers are reconciled, reversible and staged so validation status is preserved throughout, never a big-bang that ends up in a Form 483.
Let's discuss your life-sciences programme.
Share a brief overview of the R&D, clinical, manufacturing or commercial estate you're evolving, we'll arrange an introductory conversation with the relevant practice leadership.