Custom AI Development for Pharma & Biotech

Built by scientists. Compliant by design. Delivered for pharma and biotech teams who are ready to move beyond manual workflows – but need a trusted partner to get there.

Not Sure Where to Start With AI? That’s Where We Come In

Many life science and pharma teams know AI has the potential to transform their laborious workflows but are stalled by the same questions:

• How do we validate AI for a GMP environment?
• Is our sensitive R&D data safe?
• How do we move from a “cool pilot” to a production-ready, 21 CFR-compliant tool?

Whether you have a fully formed brief or just a problem you want to solve, we’ll help you get there.

At TotalLab, we specialize in taking the uncertainty out of AI. We don’t just write code; we build validated, explainable, and scalable AI solutions designed specifically for the rigorous demands of the Life Science industry.

Why Life Sciences Teams Choose TotalLab for Custom AI Development

Generic AI agencies understand algorithms, but they don’t understand your assays, your data types, or your regulatory hurdles. We don’t just write code – we understand what your data means to produce software built to last by people who speak your language.

• Scientist-to-Scientist Collaboration: Our team is comprised of PhD-level scientists, mathematicians, software developers and regulatory experts. We understand the biology behind your data, ensuring your AI models are scientifically sound, not just mathematically correct.
• Explainable AI (XAI) by Design: In a regulated environment, “Black Box” AI is a liability. We prioritize Transparent AI models where every decision can be audited, understood, and defended to regulators.
• Your data stays yours. Data privacy is non-negotiable in large pharma organizations. We build AI solutions that run on your infrastructure, trained on your proprietary data, without it ever leaving your control.
• From prototype to production. We take you from initial scoping through to a validated, deployment-ready product with clear milestones, transparent communication, and no surprises.
• Compliance built in from line one. Every solution we develop is engineered to meet GxP, FDA, EMA, and 21 CFR Part 11 requirements. Audit-ready and explainable AI isn’t an afterthought – it’s our starting point.

Our Custom AI Development Capabilities

We design and build a broad range of AI and machine learning solutions tailored exclusively for the life sciences. Our custom AI software development services include:

• AI image analysis software – automated detection, quantification, and classification for microscopy, gel analysis, colony counting, and more
• Machine learning models for QC and QA – reduce human error, catch deviations earlier, and accelerate release decisions
• AI-driven workflow automation — replace manual, repetitive processes with intelligent pipelines that free your scientists to focus on what matters
• Predictive analytics platforms – turn your historical assay and process data into forward-looking insights
• Computer vision for lab automation – real-time image and video analysis integrated directly with your instruments and LIMS
• Custom LLM integrations – private, secure large language model deployments for knowledge retrieval, report generation, and protocol assistance
• GxP-compliant AI decision-support platforms – transparent, explainable AI that satisfies even the most demanding regulatory inspectors

Not sure which applies to you? Get in touch for a free consultation and we’ll help scope the right approach.

How Our AI Development Process Works

We know pharma and biotech projects have tight governance, defined budgets, and real regulatory consequences. Our process is built around that reality.

Step 1 – Discovery & Scoping We start by understanding your workflow, your data, and your compliance environment. You’ll leave with a clear picture of what’s possible and a proposed approach before any commitment is made.

Step 2 – Prototype & Validate We build a working prototype rapidly, so you can see your solution in action early and offer your immediate feedback. This keeps you in control of direction and budget, and surfaces any technical or compliance considerations before full build begins.

Step 3 – Build & Integrate Full development follows, with regular check-ins, transparent progress, and continuous integration with your existing systems, instruments, and data infrastructure.

Step 4 – Validation & Deployment We deliver fully validated, audit-ready software with complete documentation – IQ/OQ/PQ support available where required. Handover includes documentation, and staff training.

Start with a free scoping conversation →

GxP, 21 CFR Part 11, and EU AI Act Compliant By Design

Pharma and biotech organizations face a growing and complex regulatory landscape for AI adoption. FDA, EMA, the EU AI Act, and UK MHRA are all developing specific guidance on how AI must be governed, validated, and documented in regulated environments.

TotalLab’s team understands this landscape in full. We develop AI software that is:

• Transparent and explainable – your regulators can understand what the model does and why
• Audit-ready – complete electronic records and audit trails built in as standard
• Validated – developed and tested to IQ/OQ/PQ principles, with full documentation
• Risk-classified – aligned with EU AI Act risk tiers and FDA AI/ML action plan requirements

Don’t gamble with a generic software agency that will figure out compliance after the fact.

Who We Work With

Pharmaceutical companies – from top-10 global pharma to mid-size specialty manufacturers. We help R&D, QC, and digital transformation teams build AI solutions that meet their internal governance requirements and external regulatory obligations.

Biotech and CRO organisations – fast-moving teams who need capable, scalable AI tooling without the overhead of building an in-house software function. We act as your embedded development partner.

Medical device and diagnostics companies – AI-enabled image analysis, decision-support, and data management tools built to IEC 62304 and relevant MDR/IVDR standards.

TotalLab is a registered supplier on Scientist.com, making procurement straightforward for R&D teams at large pharma organizations.

Ready to Start Your AI Project?

Whether you have a specific project in mind or just know you need to “do something with AI,” we can help. Let’s discuss how to turn your lab’s data into your next competitive advantage.

Elevate Your Pharma Operations With Compliant AI Software From TotalLab

Unlock the true potential of artificial intelligence – without the compliance headaches. At TotalLab, we specialize in custom AI software development tailored exclusively for the life sciences. Drawing on deep industry expertise, we create powerful, AI-enabled solutions that are built from the ground up to meet and exceed today’s strict pharmaceutical regulations for AI adoption.

• Pharma-First AI Compliance: Our team fully understands the current GxP, FDA, EMA, and global pharma AI regulatory guidance inside out. Every line of code is developed with regulatory clarity and audit readiness in mind, accelerating your digital transformation without you having to worry about compliance.
• Custom AI Solutions, Precisely Engineered: Whether you need AI-driven analytics, advanced automation, or decision-support tools, we design, build, and validate software to fit your exact workflows and regulatory requirements.
• Ready for Inspection—Always: Don’t gamble with generic AI software development companies –  Trust TotalLab’s proven track record of decades of life science software engineering experience to produce audit-ready, transparent, and explainable AI that satisfies even the most demanding regulators.

Let TotalLab transform your vision into a safe, compliant AI reality. Contact us today to discover how our custom AI development can deliver results—and peace of mind—for your pharma organization.

Case Study 1: AI Assisted Colony Counter

Our first case study involved taking an existing piece of TotalLab software – our Phoretix Colony Counter – and using AI and machine learning to remove the manual steps users had to go through to detect colonies within an image:

As you can see above, enhancement of this particular product with AI & ML allowed us to massively reduce user intervention, therefore time taken for analysis and remove a source of potential inter-operator variability. The result? more reliable results, quicker.

As you can also see above, each detected colony can be interacted with and adjusted and additional colonies can be manually added after detection allowing users to fine-tune the analysis if so desired. AI enhancement is provided as a tool but manual intervention still remains possible.

Who We Help:

• Pharmaceutical Companies: Streamline your R&D and compliance processes with custom-built AI solutions.
• Biotech Startups: Accelerate your growth and innovation with scalable AI analytics and automated workflows from day one.

Start Your AI Journey Today

Get in touch with us to discover how AI-powered software from TotalLab can enhance your productivity, ensure compliance, and accelerate innovation.

Frequently Asked Questions

What does custom AI software development for life sciences involve? It covers the full process of designing, building, testing, and deploying artificial intelligence or machine learning software tailored to your specific workflows, data, and regulatory environment. Unlike off-the-shelf AI tools, custom development means the solution is built around your processes – not the other way around.

How do you ensure AI software is GxP and 21 CFR Part 11 compliant? Compliance is built into our development process from the start, not bolted on at the end. This means designing for full audit trails and electronic records from day one, following a software development lifecycle aligned with GAMP 5 principles, and producing IQ/OQ/PQ-ready documentation throughout. We also keep pace with evolving FDA and EMA guidance on AI/ML in regulated environments.

Do you work with our existing data and infrastructure? Yes. We design solutions to integrate with your existing LIMS, instruments, data warehouses, and IT infrastructure. We also build AI models trained on your proprietary data – keeping it within your environment throughout.

How long does a custom AI development project take? Timelines vary by scope, but most projects move from initial scoping to a working prototype within 6–10 weeks. Full production deployment typically follows within 3–6 months. We’ll give you a clear timeline estimate during your free consultation.

Why choose TotalLab over a general AI software development agency? General agencies bring coding skills but rarely understand the regulatory, scientific, or data context of life science work. TotalLab’s team combines software engineering with genuine domain expertise — we understand GxP compliance, assay data, image analysis, and pharma QC workflows. That means less time educating us and more time building the right solution.

What happens to our data during development? Your data remains under your control throughout. We can develop and test entirely within your infrastructure, and we do not retain or transfer proprietary data outside of agreed boundaries. Data governance agreements are standard on all projects.

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