Software for pharma, biotech and instrument makers that can comply with 21 CFR Part 11 and GMP, from development teams who have been building life science software since 1989.
TotalLab is a pharmaceutical software development partner: we design, build and validate custom software for pharmaceutical companies, biotech teams and life science instrument makers. We write image analysis software, data workflow automation, 21 CFR Part 11 databases and OEM instrument software, and we deliver the validation documentation with the code. Our own products already run in GMP QC labs, so compliance is part of the design from the first meeting.
1989Our development teams have been building life science software since 1989. TotalLab Ltd since 2007.
1994Our development teams’ first OEM deal, with Bio-Rad
2009Our first 21 CFR Part 11 software for regulated labs
Scientist.comRegistered supplier, so pharma procurement teams can buy through it
Trusted by the teams at
+ more under NDA
+ more under NDA
Plus further pharma programs under NDA.
We've always found [TotalLab] support to be quick, responsive, thorough and you guys always follow up to make sure that you've addressed our needs. With software with so many different capabilities, this sort of constant customer service, backup, and advice is invaluable.
Custom pharma software we build
Six kinds of project make up most of our work. Each one is scoped, built and validated by the same team.
Pharmaceutical data workflow automation
Replace manual transcription between instruments, spreadsheets, LIMS and reports with validated pipelines. Fewer hand-offs means fewer data integrity findings and faster batch release.
What GMP compliant should mean for software →Custom image analysis software
Gels, blots, colonies, plates and microscopy, analyzed the same way every time. Our development teams have built commercial image analysis products since Phoretix 1D in 1993, so your project starts with people who already know densitometry and detection.
How custom image analysis software is built →21 CFR Part 11 and GMP databases
Audit trails, electronic signatures and role-based permissions for regulated data, designed in from the start rather than bolted on before an inspection.
21 CFR Part 11 software development →OEM instrument software
White-label or co-branded analysis software for your instrument, from prototype through to a Part 11 edition. Our development teams signed their first OEM deal, with Bio-Rad, in 1994.
OEM software development for instrument makers →AI and machine learning
Image analysis models, machine learning for QC and private language model tools that run on your infrastructure.
Custom AI development for pharma and biotech →Modernization and EU Cyber Resilience Act readiness
Move legacy lab software onto supported platforms and close the security gaps the CRA will expose.
The EU Cyber Resilience Act and your legacy software →Who we build for
Three kinds of teams come to us when off-the-shelf software won’t do the job. You’ll likely recognize yourself in one of them:
Pharma QC and analytical development teams
When your R&D or QC team needs a bespoke analysis, a validated data workflow, or automation that no vendor sells, we build it, documented and audit-ready for regulated environments.
Custom vs off-the-shelf scientific software: how to decide, and what a build costs →
Biotech startups and scale-ups
Outsource your analytical software to specialists. We take startups from prototype to an investor-ready, validated product, so you can move fast without hiring a software team, and without cutting corners on compliance.
Twenty questions to ask any life science software development partner →
Life science instrument makers
Add branded, integrated, compliant analysis and control software to your hardware without standing up a software team. We deliver white-label or co-branded software end to end, so your device does more and sells better.
OEM software development for instrument makers: how we work →
[TotalLab] after sale support is first-class [...] every response is thorough and expertly explained - not to mention how quick they reply - even if you are from down-under on the other side of the globe!
Why a specialist pharma software developer
Our development teams have built and sold analytical software since 1989: 1D and 2D gel analysis, LC-MS host cell protein analysis, colony counting, ELISA, kinetics and arrays. That is the difference between us and a general software agency. We already understand spot matching, plate layouts, densitometry and the data integrity expectations behind them, so discovery time goes on your workflow, not on teaching us the science.
Our team includes scientists, mathematicians and software engineers. The people who scope your project are the people who build it.
Twenty questions to ask any life science software development partner →
Validated from day one
Software for a regulated lab is only finished when your QA team can sign it off. We design software that can comply with 21 CFR Part 11, EU Annex 11 and GMP, with ALCOA+ data integrity built in, and we validate it with the risk-based approach of the FDA’s Computer Software Assurance guidance, following GAMP 5 where it applies.
With each validated delivery you receive a user requirements specification, functional specification, risk assessment, traceability matrix, IQ/OQ test scripts and executed results, and release notes.
Validating custom software: GAMP 5, CSA and what you should receive from your developer →
21 CFR Part 11EU Annex 11GMPEU CRA readyFull validation documentation
How a project runs
- Discovery call. A free 30-minute call to understand your equipment, workflow or idea.
- Scope & proposal. A clear plan, timeline and fixed view of what we’ll build and why.
- Agile build. We build in the open, with you, iterating on real working software.
- Validation. Testing, documentation and 21 CFR Part 11 validation where needed. See what you receive.
- Support and enhancements. Ongoing support, training and enhancement as your needs grow.
Not ready for a full build? Our life science software consultancy service covers workflow reviews, algorithm advice and bringing legacy software up to 21 CFR Part 11 and EU Annex 11.
Support from the people who write the software. The team that builds your software also supports it, in the same way it supports TotalLab’s own analysis software. This is what scientists using that software have said about our support.
The technical support we have received has been very good indeed, with questions being answered very fully and quickly. We really have been very impressed by the level of support.
Case studies
OEM · Instrument software
We built AzureSpot Pro, an OEM image analysis platform for Azure Biosystems, then a 21 CFR Part 11 and GMP-compliant edition that opened the regulated pharmaceutical market to them.
Read the Azure Biosystems case study →Biotech · Automated analysis
We turned a slow, manual 1D SDS-PAGE gel analysis, annotation and reporting process into automated software that delivers results in seconds. The team rapidly increased the throughput of its lab work and significantly reduced the time taken to deliver projects, without scaling its headcount.
Pharma · Regulated data
We built a 21 CFR Part 11-compliant database for an immunotherapy developer, giving them an audit-ready system that stands up to the scrutiny of their regulated environment.
Pharma · ATMP workflow
A leading global pharmaceutical manufacturer selected TotalLab to deliver a custom, automated ATMP workflow solution, built for GMP and 21 CFR Part 11 and harmonized across its sites.
Read the ATMP news story →See all case studies, including named projects for OEMs, pharma, biotech and academia →
I have never had a problem that [TotalLab] Support could not solve with a short phone call or a concise e-mail. They know their stuff and communicate well.
Tell us about your project
Book a free 30-minute discovery call and we’ll tell you how we’d build it, what it would take, and whether we’re the right team for the job. No obligation, no hard sell.
- Talk directly to scientists who build software, not a sales rep
- Walk away with a clear view of scope and approach
- Everything covered by an NDA
Frequently asked questions
Do you build white-label software for equipment manufacturers?
Yes. Delivering branded, integrated software alongside life science instruments is one of our core services. We handle development end to end so your team can stay focused on the hardware, and your device ships with software that adds real value.
Can you build 21 CFR Part 11 and GMP-compliant software?
Yes. We have built software that can comply with 21 CFR Part 11, EU Annex 11 and GMP since 2009, with the audit trails and documentation regulated environments require. Compliance is designed in from the start, not added on afterwards.
We're an early-stage startup. Are we too small to work with you?
Not at all. We regularly take startups from prototype to a validated, investor-ready product. You get a specialist team without the cost and delay of hiring one, and software that stands up to due diligence.
Will your software work with our existing instruments and systems?
Yes. We build to integrate with your existing hardware, data and infrastructure, whether that's controlling an instrument, ingesting its data, or connecting several tools into one workflow.
How do we get started?
Book a free 30-minute discovery call. We'll discuss your equipment, workflow or idea, and give you an honest view of how we'd approach it and what it would take.
How much does custom pharmaceutical software development cost?
It depends on the scope, complexity, validation level and integration your project needs, so we don't publish prices. After a free discovery call we send a proposal with the cost, so you know it before you commit to anything.
How long does a custom pharma software project take?
It depends on scope and complexity. A focused tool and a validated GMP system run to very different timelines, so we set out the timeline for your project in the proposal that follows the discovery call.
Do you work with pharma companies in the United States and Europe?
Yes. We work with pharma and biotech teams in the United States and Europe, and procurement teams can buy through Scientist.com. Every engagement is covered by NDA.
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