Everything you can hire me for, on one page
Independent digital-quality and AI validation advisory for pharma, biotech and CDMO. Most clients start with training or the book, and grow into the programme work. Every engagement is senior-led; I keep the number of concurrent programmes small on purpose.
Start where your month is
Validating AI in GxP, CSV to CSA, data integrity and paperless quality. On-site or online, per batch of up to 30, up to CQO level.
Contact for price → 2 · AI validation & governanceRisk tiering, intended use, Annex 22 and EU AI Act readiness, and an AI governance stack with drift and monitoring.
Scoped per engagement → 3 · QMS modernizationQMS 2.0, paperless validation, harmonization across sites, and CSV delivery that survives ALCOA+ scrutiny.
Scoped per engagement → 4 · The book & toolkitThe Company Edition from $1,250 and the validation Practitioner Pack, 92 working documents including 50 templates, 13 SOPs and 19 quick reference guides, from $5,000.
Get the tools →Training and advisory are quoted to your context, usually the same day. The toolkit and Company Edition carry list prices because they are products, ready to deliver.
The full menu
Six connected areas, built for regulated environments and inspected programmes. Each links to how the work runs.
AI Validation & Governance
Independent validation of AI, ML and GenAI in GxP. Risk tiering, intended use and the AI validation master plan; inspection readiness for Draft Annex 22, the EU AI Act, Part 11 and Annex 11.
AI in GxP governance consulting →CSV to CSA Transformation
Move from heavy CSV to risk-based Computer Software Assurance with the DRIVE framework, aligned to GAMP 5 second edition, FDA CSA and ICH Q9.
CSV to CSA transition consulting →Computer System Validation
Validation of LIMS, eQMS, ERP and equipment across the full lifecycle, with data integrity built in rather than bolted on.
computer system validation services →Paperless / Digital Validation
An end-to-end digital validation lifecycle, with evidence that stays audit-ready every day rather than being assembled before an inspection.
digital validation consulting →QMS Harmonization & Digital Quality
One quality system across sites and acquisitions: QMS 2.0, harmonized processes, and AI-assisted quality operations.
QMS harmonization consulting →Training & Enablement
Corporate training and workshops so your people run the new systems with confidence after go-live. Rated 4.9 out of 5 across 1,500+ sessions delivered.
in-house GxP training programmes →The consulting index → The frameworks behind the work → Free assessments →
Who I work with
Pharma, biotech and CDMO
QA, validation and IT teams carrying real inspection risk. The work runs from a first training or a fixed-scope diagnostic to programme steering and an advisory retainer. If an inspection is close, the paid Inspection-Readiness Review is the fastest honest first step.
Book a conversation →AI and quality-tech vendors
Product teams that need a validation framework, Annex 22 positioning and pharma credibility their customers' inspectors will accept. Independent advisory on a retainer or per-product basis, never paid endorsement.
The vendor lane →Two recent engagements, anonymised
Real programmes, real numbers, client names withheld by agreement.
From legacy CSV to a working CSA operating model in four months
A global biopharma needed its validation practice moved from document-heavy CSV to risk-based CSA without disturbing inspection readiness. The DRIVE operating discipline went live in four months: calibrated risk decisions, right-sized templates, retrained reviewers. The first quarter alone returned a 23% reduction in validation effort and 36% faster system deployments.
An AI validation framework in three months, nine AI projects live, three inspections cleared
A mid-size pharma wanted AI inside its QMS but had no way to validate it that an inspector would accept. We built their AI validation framework in three months and deployed it in two more. On those rails the client took nine AI projects live across QMS optimisation, returning savings of more than 15 million dollars, and cleared FDA, MHRA and Russian health authority inspections.
Questions buyers ask
What does an engagement cost?
Training and advisory are scoped to your context and quoted, usually the same day you ask. The two products carry list prices: the validation Practitioner Pack, 92 working documents including 50 templates, 13 SOPs and 19 quick reference guides, from $5,000, and the Company Edition of Validating AI in GxP from $1,250. Write to info@trustbridge-compliance.com with the problem and you will get a straight answer on the leanest way to solve it.
Who delivers the work?
Sachin Bhandari leads every engagement personally: 25 years in pharma quality IT, contributor to the EU GMP Annex 22 (AI) industry review, Global GAMP Steering Committee, and author of Validating AI in GxP. Delivery partners join only when a programme needs hands, and always under his direction.
Where does the work happen?
Anywhere. The practice is based in India and works with clients remotely across the US, Europe and Asia, and in person when the work earns the trip. Training runs on-site or online, sized per batch of up to 30 participants.
How do I start?
Book a 30-minute conversation. You bring the pressure you are under; you leave with three concrete next moves, whether or not we work together. If you prefer to check yourself first, the free AI Readiness Check and CSA Maturity Check each take six minutes.