Most AI programmes in regulated biotech stall at the boundary of the validated estate. The cause is a business case built without the validation, qualification, data integrity and human oversight scope that a GxP environment forces. DigiSci Consulting prices that line item first, then scopes the work against it.
Executives deciding where and whether to invest in AI before the pilot trap decides for them. An opportunity assessment run as a costing exercise. Candidate use cases are scored on value and feasibility, then priced with the validation, governance and ongoing manual control upkeep a regulated environment demands. What arrives is a business case that survives a board challenge and an inspection question.
What's delivered
Teams with a validated use case ready to move into a regulated production estate. Build and validation run as a single workstream, aligned to the FDA and EMA joint AI principles and the EU AI Act high-risk obligations. GAMP 5 categorisation is applied per configured module rather than per platform, and data integrity controls are designed in at requirements stage. Vendor pre-executed IQ, OQ and PQ is treated as vendor evidence and never as client validation.
What's delivered
Operations leaders whose data, process and compliance work against each other. The data and document estate that every downstream AI use case depends on, diagnosed and redesigned. Target architecture covers request classification, access gating and integrity controls, sequenced so adoption and data quality land ahead of any predictive layer. Delivered against defined data estate.
What's delivered
Comprehensive Operational Excellence Strategy that reduces deviation backlogs, transfer delays or CDMO risk. Manufacturing and quality problems addressed at process level by someone who has run them. Cell and gene therapy operations carry batch sizes of one, living materials and a chain of identity that cannot fail, which is why a generic deviation-reduction method breaks on contact. Scope runs from recurring deviations through tech transfer recovery to CDMO oversight.
What's delivered
Teams looking to scale AI fluency and operational efficiency. A three-tier certified programme, built around the client's own use cases and delivered platform-agnostically. Assessment is a scored instrument rather than an attendance record. Delivered to two organisations on two different enterprise platforms.
What's delivered
Organisations that need the digital and AI seat filled by someone who will also deliver the work, and software providers building for the advanced therapy market. A named senior seat inside the organisation on a defined number of days per week, carrying the digital and AI agenda end to end. The seat sets the strategy, owns the roadmap, runs delivery across service lines 01 to 05, and holds the governance and validation position in front of the board and the inspector. A second track applies the same seat to software providers building platforms for cell and gene therapy, where the constraint is what a regulated buyer will accept rather than what the product can do. Track A, embedded digital leadership. Track B, advisory for software providers in advanced therapy
What's delivered
Fixed-scope pieces you can pick and mix — proof before committing to a full programme.
A five-dimension scored read on where AI would help your operation, where it would not, and what it would cost to do it inside a validated estate. Output is a scored profile with prioritised recommendations and an indicative validation scope per candidate use case.
Analysis your AI data estate assessed against ISO/IEC 42001, covering 32 clauses and Annex A controls, scored and phased, using a standard design guide rather than pursuing certification.
Access a supplier's AI or software proposal reviewed for alignment to real business needs, governance-gate collisions, arithmetic integrity and the clauses that are absent. Findings on the last review included ROI alignment, appropriate infrastructure assumptions, and missing GxP validation, acceptance, change control and IP positions.
A first call to understand your programme, your constraints and whether we are the right fit. No obligation.
A written scope — objectives, deliverables, timeline and price — agreed before any work starts.
Principal-led work run alongside your team. Regular checkpoints, no surprises.
Deliverables and the knowledge to own them, handed to a named owner on your side.