Raycaster/ Eval

Company environment · Oral FDC · NMPA / CDE

A combination tablet under review in China

Under review; answering a formal deficiency notice. Start at the top to see what the company does, then the jobs AI models were given here and how each scored.

1What does this company do?

A drug company seeking approval in China for a tablet that combines two existing medicines.

Combining two known drugs in one tablet still needs full quality evidence and proof it behaves like taking both.

For experts

Generics sponsor before the Chinese regulator on a single 80-day deficiency-notice clock for a fixed-dose-combination quality dossier.

2Where is the product on its way to patients?

The application is under review, and China’s drug evaluation center has sent a list of deficiencies.

  1. 1Discovery
  2. 2Lab & animal studies
  3. 3Human trials
  4. 4Filing & review
    • The product is here
  5. 5Approved
  6. 6On the market

The company has 80 days to answer questions on impurities, manufacturing, dissolution and specifications.

For experts

Oral fixed-dose combination tablet; the deficiency response covers a bioequivalence waiver, impurities, dissolution, and provincial-institute verification — each drafted against the filed record.

3What is happening right now?

The deficiency notice has landed; the regulator’s reply clock is running.

Each team drafts its part of the answer from the file as it stands.

4Which jobs were the models given?

6 jobs, each graded against a specialist’s checklist.

Scores are checks passed out of checks in the list. Each model ran each job once.

JobSolOpusAstra
01Draft the formulation-similarity and bioequivalence-waiver section of the deficiency response.2/85/85/8
02Draft the answers on impurities and method validation, and update the release specification.4/86/86/8
03Draft the answer on controlling a genotoxic impurity class, and update its limits and test methods.1/83/85/8
04Draft the answers on API particle size, in-process controls, and hold times, and update the process information form.4/84/84/8
05Draft the answers on dissolution acceptance criteria and comparative-profile conditions, and update the dissolution specification.2/82/83/8
06Fold the provincial institute’s verification comments into the release specs for all three strengths, documenting every change.0/80/84/8

This company’s files stay private.

The jobs on this page are scored as part of the official 71-task benchmark. The files, the model’s steps, and each check stay unpublished, because they come from a real product’s records. To follow a job all the way down, open one of our open companion showcases (evaluated separately from the benchmark totals).

Havenor Therapeutics (fictional showcase) →
Broad Institute (public FDA record showcase) →

← Back to all company environments