QRD-Compliant. Every Time.
Eliminate approval delays caused by avoidable formatting and structural non-conformities.
A single non-compliant heading in an Annex I SmPC. A missing mandatory paragraph in Section 4.3. A German PIL that deviates from the QRD template. Each of these issues leads to rejection—costing weeks in additional review cycles and thousands of Euros in regulatory fees. Keoplan eliminates these risks at the source by automatically validating every translation and document against current EMA QRD templates before it leaves your desk.
The Hidden Costs of Manual QRD Compliance Checks
Each of these issues can cost your submission weeks or months.
Rejections & Re-submission Loops
EMA review teams return submissions containing structural non-conformities that an automated audit tool would catch instantly. Each round extends your approval timeline by weeks.
Paraphrasing of Locked Standard Statements
Generic AI tools routinely rewrite prescribed QRD standard phrases. Regulatory authorities notice. Keoplan locks these statements immutably.
Linguistic Drift in Multilingual PILs
Over revision cycles, translated SmPC documents drift from the English source. Safety statements diverge incrementally. Keoplan keeps parallel documents structurally aligned.
Review Burden on Qualified Persons
Your Qualified Person should focus on scientific accuracy, not manually verifying section numbering hierarchies. Keoplan automates the structural review layer completely.
Engineered for Regulatory Precision
EMA QRD Template Validation
Every submission is automatically checked against the latest EMA QRD template set—Annex I (SmPC), Annex II, and Annex III (PIL)—detecting missing mandatory headings, incorrect section orders, and non-compliant structures.
Standard Statement Locking
Keoplan recognizes and locks all EMA-mandated standard phrases in the source document. The AI is restricted from rephrasing them—what goes in comes out identical.
Bilingual SmPC/PIL Comparison
Perform structural comparisons between English and German versions of your product information documents. Section-level discrepancies are flagged automatically.
Patient Lay Summary Generation
Automatically generate patient-friendly lay summaries in plain language from clinical study reports, ready for EU Clinical Trials Register submission.
Audit Trail & Compliance Log
Every job is logged with source, timestamp, cost, and QRD verification results. A complete, traceable compliance document ready for inspection.
Human Expert Review Layer
Route any translation or document for final sign-off by a qualified biomedical specialist through Dr. Keogh’s expert review layer.
From Source Document to Submission-Ready File
Upload your German or English source document (DOCX or PDF)
Keoplan detects document type (SmPC / PIL / KSP) and applies the correct QRD rule set
AI translation executes with active phrase locking and mandatory heading enforcement
QRD Audit Report generated—pass or fail with section-level details
Optional: Route to human expert reviewer for final regulatory sign-off
Download your submission-ready, QRD-validated translation package
Ready to Eliminate QRD Non-Conformities?
Join regulatory teams across Europe trusting Keoplan for QRD-compliant submissions every single time.
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