Labeling and Artwork Management Solutions

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The regulatory environment has become increasingly stringent, further compounded by an active M&A environment. This has led to a growing need for label updates, local label alignment, artwork and packaging updates to ensure systems our compliant, scalable, auditable, and cost-efficient.

Indegene helps clients leverage a globally scalable and efficient Labeling and Artwork Management Solutions (LAMS) that is purpose built to meet the needs of the global life sciences industry. Indegene's ability to effectively combine clinical, regulatory, creative, and business process knowledge and expertise has made it a preferred partner for global pharma companies. Indegene's deep focus on the life sciences and healthcare allows us to bring significant clinical and regulatory perspective to our LAMS engagements, which results in better business outcomes. Our capabilities include RX, CX (consumer), devices, vaccines, OTCs, and generics.
 

 

Key Business Outcomes

 

  • Realize large-scale productivity, cost, and compliance benefits

  • Improve overall LAMS effectiveness-service consolidation; streamlining the packaging process; reducing and eliminating product recalls, and improving on-time product to market

  • Improve serviceability with an integrated shared services model, optimized write-offs, collaborative review, and approval

  • Increase competitiveness with enhanced operational efficiency, process improvements using data analytics, standardized KPIs, and measurement

  • Improve compliance and validation through approval tracking and traceability and increased transparency

SOLUTIONS
Source Label Creation and Updates

  • Core Data Sheet (CDS) creation and updates

  • International patient leaflets, USPI, and SmPC preparation

  • Clinical and nonclinical overviews preparation for CDS updates

  • PSUR updates from a regulatory standpoint

  • Source label QC services

Local Label Alignment

  • Source label to local label alignment

  • Medical assessment service

  • Mapping guides

  • Hybrid label comparison (Local label vs two source labels)

  • EU variation comparisons

  • ADR frequency comparisons

Label Updates

  • Regional label updates

  • Health authority coordination and responses to queries

  • Localization services

  • Regulatory submissions and approvals

  • Label QC services

  • Patient label creations and updates

  • SPL-PLR Services

  • End-to-end Labelling Management tool

Artwork Creation

  • Artwork creation – new labels/cartons/leaflets/foils

  • Artwork modification – text and technical changes

  • Creation of drawings and specifications for all artwork components

  • Standardization of drawings to help optimize SKUs

  • Incorporation of Braille on artwork

Proofing

  • Manual character-by-character QC

  • Verification of artwork adherence to regulatory and labeling guidelines

  • Multilingual capability: Ability to localize content

Artwork Management

  • End-to-end process lifecycle management – change request to print ready artwork

  • Knowledge of PLM platforms

  • Proprietary platform—IndegeneConnect™

  • Base-lining and benchmarking operations

  • System upgrades and UAT

  • KPI Reporting