AG.it — drug development as a project: from methods to the marketing authorization

Who it's for, and why

Head of R&D · project lead

Owns the registration timeline and the development budget. Wants to see not «who did what», but what's been invested, which commercial value of the authorization is at risk, and the 2–3 decisions that are theirs — before a stage slips at the gate.

Analyst · formulation technologist

Runs methods, validation, process, batches, stability. Wants to see which result hasn't locked in (an OOS, no stability data) and what exactly unblocks a milestone — in the language of development gates, not «closed tasks».

The pain of drug development

Registration slips late

A failed validation, a stability OOS, a deficiency letter surface at the gate meeting. The authorization date moves when it's already too late to re-plan.

Budget burns, authorization value at risk

Team, substance, pilot and validation batches, expert review — money flows out for months. And the commercial value of registration hangs on a single unclosed stage.

«Done» ≠ «validated»

Every validation task is closed — but the method isn't accepted because of an impurity OOS. A task tracker can't show this: to it, that's «N tasks done».

Statuses are about activity

Reports are about what was done, not which gates are passed and which result became true. Before registration, those are different things.

What pharma buys

State from facts

Validated / stable / dossier accepted / authorization granted — computed from lab facts and sign-offs, not from words at the gate.

Money in pharma terms

Invested (team + substance + batches + review) against the authorization value at risk. Visible at once, no Monday-morning hand-assembly.

Deviations before the gate

A validation OOS, a stability timepoint out of spec, a deficiency letter — visible as drift early, not at the gate meeting.

Critical path to the authorization

A graph of stages: where the bottleneck is — stability or validation — and what holds the registration date. You can push precisely.

How AG.it reads development — on the live demo project

A fictional modified-release generic «MR-117», built as an AG.it project: early stages accepted, method validation overdue because of an OOS, stability in progress with a 6-month deviation, the authorization ahead and at risk.

Step screenshots show the detailed (expert) view. The live demo opens in the lightweight focus mode: the full toolset is one tap away — “expert” on the bottom dock or the F key.

Step 1 · Project → Overview

The diagnosis: work is done — the result is missing

What you see

The verdict in the masthead: «Money at risk — outcome not locked in: Analytical methods validated» — that milestone came due 40 days ago but isn't accepted because of an OOS. The revenue path is a staircase of stages, validation lit red. Below: Revenue $167K · Backlog $2.2M · of which at risk $67K.

What you get

In 10 seconds: the early milestones are accepted (revenue $167K), but the validation method isn't accepted because of an OOS — there's no locked-in result. The $67K validation payment is overdue, and behind it the whole path to registration is in question (the authorization — $2M). Not «N tasks closed», but «the method isn't validated».

Step 2 · Project → Financial pulse

Invested against the authorization value at risk

What you see

Contract $2.3M · Revenue by act $167K · Cash in $142K · receivable $24K · on unaccepted milestones $2.2M. Deviation to date −$91K ($67K unaccepted + $24K receivable). Spend $228K of the $344K plan. Budget by stage: substance, batches, state fee and expert review. A month-by-month chart, plan vs fact.

What you get

The cash truth of development: ~$228K already invested, revenue on early milestones $167K — while the main $2M registration payment isn't recognised until validation and stability close. This is the «invested vs authorization value at risk» lens.

Step 3 · Project → Goal map

The critical path through validation and stability

What you see

A graph of stages by phase: QTPP → methods → validation → process → batches → transfer → stability → dossier → review → authorization. Validation (red) and stability (in progress) sit on the critical path to registration.

What you get

You see exactly the nodes that hold the authorization date: method validation and stability. You can push on the bottleneck precisely, not «speed everything up».

Step 4 · Project → Overview · «Engineer» perspective

The path to the result and the blocker — in the developer's language

What you see

The same panel in the «Engineer» perspective — not money but result: «Results path», the next milestone «Analytical methods validated», and what unblocks it — revalidating the impurity method after the OOS.

What you get

The analyst and technologist see the gate and the blocker in their language: which result didn't become true and which action closes it. One project, two truths: money for the lead, result for the team.

Step 5 · Project → Log

Deviations before the gate: OOS and stability, append-only

What you see

The log: «OOS on related substances during method validation — method not accepted, revalidation required» (May 15); «6-month stability timepoint out of specification — OOS opened» (Jun 6). On the right — the same log in a console view.

What you get

The drift is recorded as a fact with a date — long before the gate meeting. Append-only: records aren't edited, changes are added as new events. This is an audit trail, not a status from words.

The boundary with the LIMS: AG.it + your qualims, not «instead»

qualims runs the lab's operational life and GMP traceability. AG.it is the project control plane above it: it doesn't duplicate the LIMS — it reads its facts as milestone evidence and computes development state, money, and registration risk.

Fact layer · the lab

qualims (LIMS)

Runs auto-detected from LabSolutions logs (.lcd), a registry of columns and reagents, test reports, deviations/CAPA, stability, GMP audit «before/after» (Annex 11 / 21 CFR Part 11). It answers: «what happened in the lab — traceably?»

Project control · above the lab

AG.it

Doesn't run instruments or reagents. It reads qualims facts through its open REST API as evidence for project milestones. It answers: «what state is development in as a project, what's drifting, what's at risk to registration, which decision is due?»

AG.it + your qualims

A fact in qualims (the lab layer)	Proves a milestone in AG.it (project control)
Method test report (system suitability, impurity profile)	Analytical methods developed
Method validation status (incl. OOS / deviation)	Analytical method validation
Stability timepoints (0 / 3 / 6 months, degradation trend)	Stability study
Run log and batch linkage	Pilot and validation batch manufacturing

The connector is concrete: qualims has an open REST API — the AG.it ↔ qualims integration runs over it, on demand and by volume. The lab keeps living in qualims; the project lives in AG.it; the facts flow from the first into the second.

Before	After
«80% done» in a task tracker	Validated / stable / dossier accepted / authorization — computed from facts
OOS and deficiency letters surface at the gate	Deviations visible as drift early, before the gate meeting
Development budget in a spreadsheet, authorization value in your head	Invested vs authorization value at risk, on one screen
LIMS apart, project apart	AG.it reads qualims facts as milestone evidence
Status from words at the gate meeting	Append-only log of sign-offs and deviations with dates

If you hit a term

QTPP — target product quality profile: what the drug should be; it sets the development criteria.

Method validation — proof that an analytical method gives a trustworthy result (specificity, accuracy, precision, LOQ…). Without it, the data «doesn't count».

OOS (out of specification) — a result outside the spec; triggers an investigation, may require revalidation or a rethink.

Stability — the study of how the product holds the spec over time (0/3/6/… month timepoints). Often the critical path of development.

Transfer — moving the process and analytical methods to a GMP manufacturing site.

CTD — the registration dossier format (modules 1–5).

Marketing authorization (registration) — the regulator's permission to put the product on the market; entered in the state register.

Deficiency letter — the reviewer's request to revise the dossier; it pushes the registration date.

Drug development is a project. And its state isn't «how many tasks are closed»

Who it's for, and why

The pain of drug development

What pharma buys

How AG.it reads development — on the live demo project

The diagnosis: work is done — the result is missing

Invested against the authorization value at risk

The critical path through validation and stability

The path to the result and the blocker — in the developer's language

Deviations before the gate: OOS and stability, append-only

The boundary with the LIMS: AG.it + your qualims, not «instead»

What changes for a pharma project

If you hit a term