One operator, both halves of the problem.
Biotech rarely gets to hire someone who understands the manufacturing floor and the AI stack at the same time. The two usually arrive as separate consultants, on separate contracts, arguing past each other. DigiSci Consulting exists to hold both in one seat.
Kwok Pang — Founder & Principal Consultant
I have spent my career at the point where advanced therapy manufacturing meets the systems that run it. Cell and gene therapy carries batch sizes of one, living materials and a chain of identity that cannot fail, which is what breaks the generic digital playbook on contact. Everything DigiSci Consulting sells comes out of running that problem rather than studying it.
The work I do now is the same problem with AI added to it. Where AI belongs inside a validated estate, what it costs to put it there, and how to hold the position in front of a board and an inspector. I write the specifications, run the delivery and sign the recommendation.
“Domain expertise and AI capability should not live in two different consultants. In advanced therapy, the interesting problems only show up where they meet.”
What DigiSci actually shipped
Each line below is a delivered artefact, not a capability statement.
Quality systems built to a locked specification
163 compliant documents produced against a 33-of-33 automated layout gate, spanning GMP, GCP and corporate governance.
Systems validated
GAMP 5 categorisation applied per configured module, a six-link traceability chain from requirement to evidence, and vendor pre-executed IQ, OQ and PQ treated as vendor evidence rather than client validation.
AI governance at standard-level depth
An ISO/IEC 42001 gap analysis across 32 clauses and Annex A controls, scored and phased over 12 to 18 months, with the judgement to recommend the standard as a design guide rather than a certification chase.
AI capability measured rather than assumed
A three-tier programme assessed with a scored instrument: Trainees assessed, evidence records passed, marked dual-blind with full assessor consensus.
Business cases that price the validation line item
An ROI model presented break-even first, with a published stress test designed to break the case, and an assumptions register carried as a validation instrument.
DigiSci exists to help advanced-therapy manufacturers reach an AI-driven future without trading away the quality and compliance that make their products safe.
A small, senior-led practice on purpose.
DigiSci's capacity comes from the tooling rather than from headcount, which is why a single operator can carry eleven concurrent workstreams across three clients and still deliver at document-set volume. The delivery record is the evidence for the AI-native claim.
Principal-led
The person who scopes the work is the person who delivers it. There is no handover to a junior team, because there is no junior team.
A deliberate client count
DigiSci Consulting takes on a small number of engagements at a time. Every engagement carries a written scope, a named owner on the client side and a defined exit.
Independent
DigiSci Consulting Limited is founder-owned, with no external investors, no vendor commissions and no exclusive platform partnerships. Advice on a vendor is advice, not a referral.