USPI, MedGuide & PPI — PLR and PLLR ready.
Full-service authoring and maintenance of US Prescribing Information (USPI / PI), Medication Guides (MedGuide), Patient Package Inserts (PPI) and Instructions for Use (IFU), aligned to FDA's Physician Labeling Rule (PLR) and Pregnancy and Lactation Labeling Rule (PLLR).
What we deliver
PLR-format USPI
Highlights, full prescribing information, boxed warnings and section numbering per 21 CFR 201.56/57.
PLLR-compliant 8.1/8.2/8.3
Pregnancy, Lactation and Females and Males of Reproductive Potential subsections.
MedGuide & PPI
Patient-facing labeling drafted to FDA's plain-language and format expectations.
Carton & container labels
Principal Display Panel content for primary and secondary packaging.
Labeling supplements
CBE-0, CBE-30 and Prior Approval Supplement (PAS) authoring and tracking.
SPL bridge
Hand-off from clean USPI to FDA Structured Product Labeling (SPL) for ESG submission.
From USPI to SPL in one controlled flow
Alnexia's USPI authors work alongside the SPL team so that approved content moves from Word to validated HL7 SPL XML without re-keying — eliminating the common source of typographical findings during FDA review.
Artefacts you receive
- USPI (Word, tracked, redlined vs reference)
- Medication Guide / PPI / IFU
- Carton & container label content
- PLR/PLLR compliance checklist
- Labeling supplement cover letter & narrative
Sourced from regulators and industry leaders
- FDA PLR — 21 CFR 201.56/57 — eCFR
- FDA PLLR final rule — U.S. FDA
- FDA Medication Guides — U.S. FDA
Ready to scope this work?
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