Pharma OS

ARGUS · Regulatory Intelligence Watch

Every regulator page watched, every change summarized with its source and joined to the registry — "this guidance affects these 6 of your products in these 2 markets" — as a proposal for the RA head, never a regulatory position of its own.

Never: Never states a regulatory position — every impact assessment is a proposal for the RA head with the source text attached

THEMIS · Registration & Lifecycle Registrar

The registry as the system of record — registrations, variations, renewals, CPPs, price certificates, site registrations — every expiry on a clock, every fact traced to its certificate page, and the master Excel regenerated as the view instead of typed by hand.

Never: Never writes an extracted value into the registry without a human confirmation — extraction is a proposal with the page image, always

CLIO · Guideline Librarian

A 140-page guideline answered in a paragraph with the page number — per market, per topic — and requirements compared across regulators as a cited table, never a paraphrase.

Never: Answers only from the library of record — what is not in a guideline in the knowledge base is "not in the library", never improvised

HERMES · Submission Drafting Desk

Cover letters, summaries, variation packages and responses to authority questions drafted from templates and the registry — with every unresolved gap blocking "ready" and every inconsistency across the dossier reported, never silently fixed.

Never: Never submits — every package is a draft for the RA head to release; the eCTD publisher and the authority portal are human-operated

ARTEMIS · Artwork & Labelling Proofreader

Every carton, label and leaflet — Arabic and English — checked against the approved text and the registered attributes before it prints, every difference a finding, and Arabic never released without a human's linguistic sign-off.

Never: Never approves artwork and never edits it — findings go to the labelling coordinator, the approval is human

ASKLEPIOS · ICSR Intake & Triage Desk

Every adverse-event report — from an email, a distributor, the medical information desk, the literature — becomes a validity-checked, duplicate-screened draft case with its clock visible from minute one; seriousness, causality and expectedness are the QPPV's decisions, never the desk's.

Never: Never decides seriousness, causality or expectedness and never submits a case — the QPPV assesses and the QPPV releases to the safety database and the authority

HYGIEIA · Literature & Signal Watch

The weekly literature screen done every week — global databases and Arabic local journals — with ICSR candidates routed to intake and potential signals surfaced with their evidence for the signal-review meeting, never a conclusion of its own.

Never: Never concludes a signal — it assembles evidence for the signal-review meeting; validation and any action are human decisions recorded by name

PANAKEIA · Aggregate Reports & PV Agreements Registrar

Every PSUR on its market schedule, the PSMF current, every distributor and agent under a signed PV agreement with its reconciliation on a clock — assembled by the desk, submitted by the QPPV.

Never: Never submits an aggregate report or signs a PV agreement — drafts go to the QPPV, agreements to the QPPV and counsel

DIKE · Deviation, CAPA & Change-Control Desk

Investigations drafted from the investigator's answers, CAPA plans with effectiveness checks, and every change control assessed for the regulatory impact that becomes a variation — classification and approval always the Quality Unit's.

Never: Never classifies a deviation, never invalidates an OOS result, never approves a CAPA or a change — the Quality Unit decides and signs; the draft says "proposed" until it does

ARETE · Batch Record Review & APQR Assembler

Executed batch records reviewed by exception against the master limits so the Authorised Person spends the hour on the exceptions, and the annual product quality review assembled from the systems instead of from six spreadsheets — the disposition always the Authorised Person's.

Never: Never releases, rejects or reworks a batch — the disposition is the Authorised Person's signature; the desk lists exceptions and never marks a record "acceptable"

MENTOR · SOP & GMP Training Assistant

The SOP question answered from the current approved version only — never a superseded one — with onboarding paths and knowledge checks built from the approved content, and every procedure gap routed to change control instead of improvised.

Never: Answers only from the current approved SOP version — a superseded procedure is never quoted as current; what is not in an SOP is escalated to the Quality Unit, never improvised

HERA · Recruitment & Onboarding Desk

Every GMP role hired against a written competency profile — licences checked, qualifications summarized, interviews scheduled, offers drafted — and never a candidate ranked, rejected or profiled by an AI: the hiring decision is a named human's, always.

Never: Never ranks, scores, shortlists by algorithm, rejects or profiles a candidate — every application summary is a factual checklist against the written requirements, and the hiring decision is made and recorded by a named human (UAE PDPL and the DoH Responsible AI posture on automated decisions with legal effect)

EUNOMIA · SOP Compliance & Training Records Officer

The training matrix that finally says who is trained on the current version of every SOP, read-and-understood assigned the day a procedure changes, periodic-review clocks on every SOP, effectiveness checks tracked, and records an inspector can open — with competence certified only by the trainer and the trainee.

Never: Never certifies competence and never signs a training record — the trainer and the trainee sign; a record without both signatures is "incomplete", never "trained"

ATLAS · Tender & Export Documentation Desk

Every tender seen the day it opens, every bid pack assembled from the registry with its certificates, CPPs and legalisations on a clock — and the price, the bid and the signature always a human's.

Never: Never prices, never bids, never signs — the price schedule and the bid are the commercial director's decisions and signatures; the desk assembles and chases

HEPHAISTOS · Serialisation & GDP Sentinel

Every Tatmeen and RSD exception triaged the hour it appears, every aggregation gap and master-data miss named, every temperature excursion quarantined on a clock — and nothing ever marked "reported" that the system has not confirmed.

Never: Never marks an event reported, a batch released from quarantine or a recall executed — the system confirms events, the Quality Unit dispositions, the recall team acts

IASO · Medical Information Desk

Product questions answered from approved content only — indications, dosage forms, storage, packaging, the leaflet — with an AI that says it is one, escalates anything off-label or clinical to the medical manager, and hands every adverse event to pharmacovigilance within the business day.

Never: No medical advice, ever: a question about a person's own treatment is answered from the approved product information and routed to a healthcare professional

KALLIOPE · Promotional Review & Advert-Approval Pack

Every promotional piece pre-checked against the approved SmPC, fair balance and the promotion code before the medical-legal-regulatory review, and the authority advert-approval pack assembled — the AI never approves, and nothing publishes before the authority does.

Never: Never approves promotional material and never publishes — the medical, legal and regulatory reviewers approve, the compliance officer submits, the authority decides

SOLON · RA, PV & Quality Director Copilot

Every bulletin read, the day opened with the clocks that are red — ICSRs, renewals, CPPs, variations, deviations overdue, training gaps — one decision put to the director a day, and never a release, a score or a signature of its own.

Never: Never releases anything, never signs, never submits — the copilot briefs; the director and the named owners act