Articles tagged with “pharmaceutical-labeling”

Structured Product Labeling (SPL): Automation & AI Trends

Explore FDA Structured Product Labeling (SPL) standards, current automation challenges, and how AI integration optimizes pharmaceutical regulatory workflows.

40 min read

2/23/2026

structured product labeling spl automation fda compliance pharmaceutical labeling regulatory affairs ai in pharma xml data standards hl7 standards generative ai electronic labeling

Using GenAI to Draft Local Label Deviations in Pharma

Explore how GenAI helps manage pharmaceutical labeling in 2026. Learn to draft local label deviations from a CCDS using AI tools like Veeva AI Agents, and understand FDA-EMA guidance on AI in regulatory compliance.

55 min read

11/24/2025

generative ai pharmaceutical labeling local label deviation veeva vault rim ccds regulatory affairs life sciences regulatory compliance

Veeva RIM for Labeling: A Guide to 5 Automated Workflows

Learn how Veeva RIM automates end-to-end pharmaceutical labeling. This guide explains 5 core workflows for label change management and regulatory compliance, updated with 2025–2026 platform enhancements, AI Agents roadmap, and EU ePI developments.

50 min read

11/24/2025

veeva vault rim pharmaceutical labeling labeling workflows end-to-end tracking label change management regulatory compliance life sciences ccds

Pharma Labeling Operations: A 6-Month Pre-Approval Checklist

Get a 6-month checklist for pharmaceutical labeling operations. Updated for 2026 with DSCSA enforcement deadlines, FDA PMI rule status, EU ePI developments, and current recall data.

40 min read

11/23/2025

labeling operations pharmaceutical labeling regulatory approval fda labeling requirements gmp product launch checklist serialization 21 cfr 201.56

Structured Product Labeling (SPL): A Guide to Data Integrity

Updated 2026 guide to Structured Product Labeling (SPL) and data integrity. Covers FDA mandates, EMA ePI roadmap, Health Canada XML-PM, FHIR standards, and ALCOA+ compliance for pharmaceutical labeling.

35 min read

11/23/2025

structured product labeling spl data integrity pharmaceutical labeling regulatory affairs fda regulations hl7 alcoa+

e-Labeling & eIFU: Which Countries Accept QR Codes (2025)

This comprehensive 2025 guide details e-labeling (e-IFU) regulations worldwide. See our country-by-country analysis of QR code acceptance for medical devices &

35 min read

11/23/2025

e-labeling eifu qr codes medical device labeling regulatory compliance instructions for use pharmaceutical labeling eu mdr fda regulations

HL7 FHIR for Labeling: A Guide to the XML & SPL Transition

A comprehensive guide to transitioning from XML-based SPL to HL7 FHIR for e-labeling. Updated for 2026 with EMA go-live timeline, Jordan mandate enforcement, FDA PQ/CMC STU2, and latest FHIR adoption data.

45 min read

11/22/2025

hl7 fhir e-labeling pharmaceutical labeling healthcare interoperability regulatory compliance data standards

Pharma Safety Labeling Updates: A 90-Day Cascade Model

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, covering FDA 505(o)(4) guidance, EMA variations framework, AI-powered PV tools, and sub-90-day implementation strategies.

25 min read

11/22/2025

pharmaceutical labeling pharmacovigilance regulatory affairs drug safety cascade communication company core data sheet global affiliate management

CCDS vs. Local Labels: Managing Global Labeling Deviations

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations, including EMA ePI, IDMP compliance, and AI-powered labeling tools for regulatory compliance

45 min read

11/22/2025

ccds global labeling labeling deviations pharmaceutical labeling local labels regulatory affairs structured authoring label harmonization