AI/ML software development
Design and build software for biotech research, data analysis, and operational workflows—from model prototyping and scientific data pipelines to internal tools and cloud-ready applications.
Explore AI/ML developmentBuild biotech
software that can
stand up to scrutiny.
Bio-Consultant helps biotech teams design and develop AI/ML software while planning for the regulatory expectations around it. One partner, from technical direction through documentation and readiness.
Technology and regulation, considered together.
The earlier these decisions meet, the fewer gaps teams have to close later.
Regulatory affairs
Translate applicable expectations into clear requirements, documentation priorities, and a practical readiness plan for your product, software, or process.
Explore regulatory supportPython · R · TensorFlow · PyTorch · AWS · GCP
FDA 21 CFR Part 11 · EU IVDR · ISO 13485
A clear path through complex work.
Every engagement starts by clarifying the decision, the evidence it requires, and the constraints the work must respect.
Frame the problem
Align on the scientific goal, users, data, constraints, and regulatory context.
Build the right system
Develop the model, software, or workflow with clear technical decisions and fit-for-purpose documentation.
Prepare what comes next
Identify gaps, strengthen the evidence and documentation, and define the next technical or regulatory step.
One conversation across the whole problem.
Software and regulatory work are often separated until late in development. Bio-Consultant keeps them connected, so engineering choices reflect the realities of biotech and regulatory planning stays grounded in the system being built.
Bring us the hard part.
Tell us what you’re building, where it is stuck, and what it needs to satisfy. We’ll help make the next step concrete.
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