Where AI meets regulated operations.
DigiSci Consulting helps biotech and pharmaceutical organisations design and implement AI transformation strategies that deliver measurable operational value.
Biotech has hit an operational turning point.
Advanced therapies have moved faster than the operations meant to make them. Batch sizes of one, living materials, and a chain of identity that cannot fail introduce manufacturing and quality problems with almost no precedent to lean on.
AI could close much of that gap. Most implementations stall at the point where the system has to be validated, evidenced and defended inside an inspected environment, and that scope was never budgeted.
DigiSci Consulting works at the junction between what advanced-therapy operations need and what AI can deliver under GxP.
Advice grounded in real GxP operational use cases, not just a slide deck. Digisci's founder has extensive operational experience through over two decades in the industry.
Domain expertise and AI fluency, in one place.
Generalist AI consultancies do not understand GMP. Biotech specialists rarely understand AI. Digisci uniquely applies AI to real business challenges with quantifiable impacts.
Domain depth
Experience with the teams who run tech transfers, close deviations and sign off batch records. The advice comes from being involved.
AI built for validated estates
GAMP 5 categorisation applied per configured module. Data integrity and change control designed in at requirements stage.
Regulatory position
GxP, ALCOA+, Annex 11, Part 11, ISO/IEC 42001 and draft Annex 22 are the starting assumptions of the design.
Strategic clarity
DigiSci Consulting states what is real, what is fixable and what it will cost. One recommendation, signed by the person who delivers it.
Six lines, done at a senior level. Grounded in decades of experience.
AI Transformation Strategy
Where AI creates value in your operation, and the sequence to get there with the validation scope priced in.
AI Implementation Programmes
From use case to production inside a GxP environment, with the validation evidence built as the system is built.
Digital Operations Transformation
The data and document estate every AI use case depends on, diagnosed and redesigned.
Operational Excellence
Root-cause deviation reduction, tech-transfer recovery, and CDMO oversight that holds up under inspection.
AI Training & Enablement
Immersive programmes built on your own workflows, assessed with a scored instrument.
Fractional Chief digital officer
A named senior seat carrying the digital and AI agenda, and an advisory track for software providers building for advanced therapy.
The technology was never the hard part.
Deploying it under GxP is what breaks most implementations. Data integrity, change control and a defensible audit trail decide whether an AI system survives an inspection.
Recent engagements.
Client details are anonymised at their request. The problems and outcomes are real, as reported by the clients.
An AI-enabled regulatory authoring platform
Regulatory applications were manually created by SMEs, spending hundreds of consulting hours reviewing hundreds of relevant documents over a 6+ month process.
We led the programme with the external technology providers, bridging SME needs with the technology providers implementation that exceeds the client specifications.
Accelerating authoring by 40-60%, while reducing SME resourcing.
A digital PQS blueprint for a scaling therapy biotech
Batch release ran on disconnected spreadsheets, with batch review averaging 8-10 days as the team scaled for Phase 2.
We delivered a digital blueprint: identification and quantification of opportunities, an implementation strategy, and multi-vendor evaluations and recommendations.
Implementation strategy with detailed multi-vendor evaluation assessments, leading to a recommended vendor with full total cost of ownership modelling.
AI training across a 80-100 FTE organisation
Establish AI governance and build AI fluency across a 80-100 FTE organisation.
We designed an immersive, tiered AI training programme combining classroom and self-learning, grounded in organisational use cases.
Tailored 3-tiered AI training for 80-100 FTEs, delivered over 3 months. Qualified training metrics to demonstrate adoption.