Systems we know well
Who we work with
We work with the people behind the science.
From clinical-stage companies to commercial ones, and everyone in between.
Biotech
You are moving fast through the clinic. We get your validated systems in place without slowing you down.
Pharma
Your systems hold years of regulated records. We help you change them carefully.
CROs
Your sponsors will audit you. We make sure the systems and the paperwork are ready when they do.
Medical device
Quality and finance both answer to auditors. We build systems that hold up for both.
Services
Here is what we can take off your plate.
01
Employment Augmentation
Experienced life sciences IT, project and validation people placed into your team, contributing from the first week.
02
End-to-End Work Management
One front door for requests, clear approvals and disciplined delivery, from intake to go-live.
03
FDA Compliance Across All GxP Areas
Risk-based validation that leaves you with systems and documentation ready for inspection.
04
Hub: Intake-to-Delivery Software
Our own platform for intake, approvals, capacity and project tracking, built for GxP and SOX.
Not sure where to start?
That is fine. Tell us what you are trying to get done and we will help you sort it out.
Who we talk to
Everyone at the table gets what they need.
A GxP system is never just an IT project. We listen to each team and keep everyone on the same plan.
IT
A clean build your team can support after we leave.
Quality
A risk-based validation package that follows your SOPs.
Regulatory
Submission records you can trust, in systems that meet Part 11.
Clinical
Study systems and training records that are ready when inspectors ask.
Safety and biostatistics
PV systems and SAS environments validated for regulated use.
Finance
Controls that pass a SOX audit and do not slow down month-end.
Supply chain and procurement
Purchasing that moves from request to payment without retyping.
Legal
Contract workflows with a record of every approval.
Making a difference is a conversation away.
Tell us what you are working on. We would be glad to hear about it.