Artless Passion is the world’s most exacting pharmaceutical RegTech practice.

We do not write documents. We forge the artefacts that regulators, Swissmedic inspectors, and Big-4 audit partners quietly adopt as the unspoken global standard.

Every single page is authored under two proprietary, publicly inspectable protocols that exist nowhere else on earth:

Reality Check Protocol (RCP v1.2 Extreme Rigor Edition)

Deterministic, non-compensatory verification of traceability, compliance, evidence quality, and quantified risk. Consensus is never accepted. Uncertainty is never rounded away.

PLATINUM–IRIDIUM v4.0

The only normative AI governance framework that enforces independent third-party re-execution, group-wise fairness, adversarial robustness, and full energy/CO₂e accounting under the EU AI Act.

These protocols are not optional. They are non-negotiable.

Artefacts currently licensed to sponsors and Tier-One consultancies on five continents

- ICH M7(R2) Nitrosamine Risk Assessment & Purge Calculation Master Pack (40 pp)

- EU AI Act Conformity Assessment Playbook for High-Risk Pharmaceutical QC/QA AI Systems (Annex IV–VII ready)

- Virtual Pharma QMS Governance Manual (ISO 9001:2015 + ICH Q10 + EU AI Act integrated)

- Scope 3 Emissions & REACH PFAS Risk Integration Guide with Bayesian assurance registers

- Global Nitrosamine Regulatory Convergence Matrix 2025 (EMA / FDA / Swissmedic / Health Canada)

- High-Risk Classification Memos · Evidence Logs · Option 4 Decision Trees · PLATINUM–IRIDIUM v4.0 ·
RCP v1.2

Distinguishing hallmarks present on every page

- Forensic traceability established exclusively via public DOI/URL provenance

- LaTeX typeset to Lancet / Big-4 presentation standard

- Explicit ring-fenced, non-operational disclaimer in red

- Deterministic scoring, uncertainty bands, non-compensatory safety gates

- Zero unsubstantiated claims

November 2025

- 100+ artefacts licensed worldwide

- Fixed-price briefs USD 12,000 – 52,000

- Average artefact length 112 pages of regulator-ready material

- Instructions typically received within hours of confidential outreach

If the objective is documentation that is no longer questioned — but quoted, forwarded internally, and treated as the de-facto standard — you have reached the correct practice.

Robin Alighieri Lindgren

Principal Author & Governance Architect

Artless Passion · Pharmaceutical RegTech Series

November 2025

Elite pharmaceutical RegTech practice delivering forensic, non-operational governance artefacts for global sponsors.