Packaging Artwork and Labeling

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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 packaging, artwork and labelling that is compliant, scalable, audit-able and cost efficient. 

Indegene helps clients leverage a globally scalable and efficient Packaging, Artwork and Labeling Services (PALS) hub that is purpose built to meet PALS needs for global life sciences industry. Indegene's ability to effectively combine clinical, regulatory, creative, and business process knowledge and expertise has made it a prefered partner for global pharma. Indegene's deep focus in life sciences and healthcare allows us to bring significant clinical and regulatory perspective to our PALS engagements which results in better business outcomes. Our capabilities include Rx ,Cx (consumer), vaccines, OTCs and generics.
 

 

Key Business Outcomes

 

  • Realize large scale productivity, cost and compliance benefits

  • Improve overall PALs 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

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  • PALS_RHS Ad2_Ver1.03-01
  • PALS_RHS Ad3_Ver1.03-01

SOLUTIONS

Regulatory Affairs

  • Core Date Sheet updates

  • International patient leaflets, USPI, and SmPC preparation

  • Clinical and nonclinical overviews preparation for CDS updates

  • PSUR updates from a regulatory standpoint

  • Document approvals

Labeling Updates

  • Register a request

  • Confirmation on label changes and updates

  • Translation of Local Product/ Patient Labels

  • Assessment and approval

Artwork Creation

  • Artwork creation – new packs

  • 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 checks

  • 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