Prepare PQRs, organize CTD quality content, and review supporting records with an AI Engineer trained on your procedures. Your specialists retain the judgment and approval.
Meet your AI EngineerCoxwave used work procedures and questions with QA specialists to reproduce the document preparation process, from source discovery and template mapping to narrative writing and verification policies.
Select a record to inspect its context.
A PQR prepared in your required format, with source references, discrepancies, and unresolved items ready for QA review.
Bring the work behind PQRs and CTD quality documentation into one connected process. Your Engineer collects evidence, applies your procedures, and prepares the material your specialists need to review.
PQR writing automation
A PQR draws on records spread across enterprise systems, spreadsheets, and laboratory documents. Specialists gather the evidence, map every section, and write the narrative while checking accuracy throughout.
Coxwave used work procedures and questions with QA specialists to reproduce the document preparation process, from source discovery and template mapping to narrative writing and verification policies.
PQR supports periodic product and process review. The Common Technical Document organizes information used in regulatory applications. For quality documentation, Module 3 contains the detailed body of information, while Module 2.3 provides the Quality Overall Summary. An Engineer can help gather, map, and draft this material from your approved sources. CTD work is scoped with QA, CMC, and regulatory colleagues; it is a separate workflow from PQR preparation, with its own structure and review criteria.
The difficult parts of document preparation often sit between the fields: which record takes precedence, how an unusual case should be described, and what requires further explanation. Coxwave captures those conventions through work procedures, expert questions, and paired examples of source material and completed reports. Case-specific knowledge packs make that reasoning available to the Engineer instead of leaving it in one specialist’s memory.
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PQR preparation is grounded in Coxwave’s pharmaceutical project experience. CTD quality-content preparation is an additional workflow to configure with your QA, CMC, and regulatory specialists, using your source documents, dossier structure, and review criteria.