Seven stages, two foundations, one honest question in each.
A molecule travels the seven stages below in that order. Quality and engineering are not stages — they run underneath all seven, which is why they sit where they do on the diagram and why an AI system inherits the GxP flavour of the process it touches rather than the flavour of the company that owns it.
Pick a function
Seven stages in the order a molecule travels. Quality and engineering are not stages — they run underneath all seven.
Discovery & preclinical
Target identification, generative chemistry, structure prediction, ADMET and the new approach methodologies replacing animal studies — what the models can and cannot do yet.
- Target identification & validation
- Generative & de-novo design
- Structural biology
- ADMET & translational safety
- Lab automation
Clinical development
Protocol design, site feasibility, recruitment, monitoring, data management and the trial master file — where AI moves cycle time and where it only moves slideware.
- Protocol design & feasibility
- Site selection & recruitment
- Clinical data management
- Risk-based monitoring
- eTMF & document operations
Regulatory affairs
Submission authoring, labelling, RIM, health-authority responses and regulatory intelligence — plus what the FDA and EMA now expect you to prove about the model itself.
- Submission authoring & publishing
- Labelling & IDMP
- Regulatory information management
- Health-authority correspondence
- Regulatory intelligence
- Named Data Ownership Beats Any Agent
- Costing a Health Authority Query Response Before You Automate It
- Your FDA Reviewer Switched Models
- FDA's Seven-Step AI Credibility Framework — And the Regulatory Operations AI It Never Covered
- What EMA Permits When AI Drafts Your Product Information
- eCTD 4.0 in Japan, Europe and America — and Why Publishing Should Stay Deterministic
- Ninety-Seven Percent Faster, Seventy Percent Complete
Manufacturing, CMC & supply
Deviation triage, batch record review, process modelling, forecasting and inspection — the GMP estate, where the validation bar is highest and the payback is fastest.
- Deviation & CAPA triage
- Batch record review
- CMC & process development
- Supply planning & forecasting
- Visual inspection & PAT
- Review by Exception After Twenty Years of Trying
- FDA's First AI Warning Letter Cites a 1978 Rule
- Serialisation Proves Where a Package Went, Not Whether the Next One Ships
- Digital Twins Cannot Release Your Batch
- What Regulators Have Actually Approved, Cited and Refused in AI-Enabled Manufacturing
- Why Adding Agents Makes Deviation Investigations Worse
Commercial & marketing
Content supply chain, MLR review, omnichannel orchestration and field effectiveness — the function with the most AI spend and the most promotional-compliance risk.
- Content supply chain
- MLR & promotional review
- Omnichannel orchestration
- Field force effectiveness
- Account intelligence
Medical affairs & market access
Field insights, medical information, publications, evidence synthesis, payer dossiers and HTA — the evidence functions, and the compliance line AI keeps walking into.
- Field medical & insights
- Medical information
- Publications & literature
- HEOR & evidence synthesis
- Payer & HTA submissions
Pharmacovigilance & safety
Case intake, coding, narratives, literature screening, signal detection and aggregate reports — the highest-volume regulated text work in the industry.
- ICSR intake & case processing
- MedDRA coding & narratives
- Literature monitoring
- Signal detection
- Aggregate reporting
GxP, validation & assurance
GAMP 5, Annex 11, draft Annex 22, Part 11, CSA, data integrity and AI governance — how you prove to an inspector that a system nobody can fully predict is under control.
- Computer system validation
- Computer software assurance
- Data integrity & ALCOA++
- AI governance & the EU AI Act
- Audit & inspection readiness
- How to Validate a Non-Deterministic LLM Without Pretending It Is Deterministic
- Your Validated Model Has a Retirement Date
- Human Oversight Is a Control You Qualify, Not a Sentence in Your Risk Assessment
- Validating AI Under GxP in 2026: What Binds You, What Is Draft, What Inspectors Cite
- Computer Software Assurance Is Device Guidance — Cite It for a Drug System and Fail
- EU GMP Annex 22, Clause by Clause
- EU GMP Annex 22: What the AI Annex Actually Says
- Nineteen Pages, Seventeen Chapters: The Annex 11 Revision Clauses That Cost Money
Architecture & economics
Retrieval, agents, evaluation, integration, cost and the honest arithmetic of build versus buy — what the consultant reports get right and where they are quietly circular.
- Architecture & integration
- Evaluation & benchmarking
- Build vs buy
- Cost & ROI
- Operating model