Custom Software Development

Full-cycle product engineering — discovery, design, build, deploy and support. We work in dedicated squads or augment your team, on web, mobile and cloud platforms.

SaaS & Cloud Platforms

Multi-tenant SaaS delivery for our products, plus custom cloud platforms on AWS or Azure — with the security, observability and SLAs that enterprise demands.

Regulatory Technology

Deployment, configuration and operation of our eCTD, ePI and QMS products — tailored to your therapeutic areas, markets and submission cadence.

Consulting & Advisory

Architecture reviews, regulatory tooling strategy, vendor consolidation, and digital transformation roadmaps for life-science and enterprise teams.

Implementation & Migration

Move off legacy submission tools, paper-based QMS or fragmented ePI workflows — with a clear plan, validated migrations and minimal disruption.

Managed Support & SLAs

Production support, monitoring, validation maintenance and release management — so your in-house team can focus on the science, not the systems.

Computer System Validation (CSV)

End-to-end CSV services for GxP systems — we prepare IQ, OQ and PQ protocols and reports, validation plans, risk assessments and traceability matrices, all aligned with GAMP 5 and 21 CFR Part 11.

How we work

A delivery process built for regulated work

Our engagements are predictable, transparent and validation-friendly from day one.

01

Discover

Workshops with your stakeholders to capture process, regulatory and technical requirements — and define success.

02

Design

Architecture, UX flows, and validation plan — reviewed and signed off before code is written.

03

Build & Validate

Iterative delivery in two-week sprints, with continuous testing and validation evidence collected as we go.

04

Run & Improve

Production support, monitoring and a roadmap of improvements — driven by usage data, not guesswork.

Engagement models

Pick the model that fits

Whether you need a turnkey delivery or extra hands on your existing team, we'll structure the partnership around your goals and constraints.

Fixed-scope project

Defined deliverables, milestones and price — best for well-scoped builds, migrations and implementations.

Dedicated team

A cross-functional squad working as an extension of your team, with predictable monthly billing and full ownership.

SaaS subscription

Cloud-hosted access to eCTD, ePI or QMS with tiered plans, onboarding and ongoing support included.

Have a project in mind?

Tell us about your goals and constraints — we'll come back with a clear recommendation and timeline.

Start a conversation