Labeling and Packaging

Transform Labeling and Packaging with Intelligent Automation Services from Syntel

Digital Services

Overview

At any given moment, life sciences companies must handle a universe of SKUs, labeling standards, and packaging requirements for different geographies and languages. Each one affects packaging and design, marketing, manufacturing, regulatory, R&D, and printing.

Syntel enables life sciences companies to overcome these challenges with scalable, end-to-end solutions delivered in Managed Services and Shared Resourcing models that reduce risk and improve efficiency.

Syntel’s automated LPaaS (Labeling and packaging as a service) is an integrated IT and KPO solution that employs automation to reduce product recalls, eliminate waste, reduce cycle time, and deliver savings on hardware and printing costs. Syntel’s solutions also ensure that your brand and messaging stay consistent from the manufacturing floor all the way to the consumer’s home.

Offerings

Label Consulting, System Implementation & Validation

  • Labeling assessment
  • Process harmonization
  • ADR frequency comparison
  • GS1 implementation 
  • Data migration
  • Regulatory compliance
  • Computer validation system
  • CCDS,  CCSI,  RSI, SmPC,  USPI,  Patient Leaflets, SPL for Pharma

Package Design & Development

  • Packaging review and concept development
  • Requirements definition, supplier review and assessment
  • Packaging system design and drawing development
  • Graphics and tool development
  • Sterile packaging services for Pharma

Artwork Creation & Change Management

  • Artwork creation, modification and standardization
  • End-to-end lifecycle management
  • Label comparison, authoring and updates for Pharma
  • Language translation
  • Data migration
  • Regulatory compliance 

Quality Control, Proofing & Validation

  • End-to-end automated QC for documents
  • Verification of artwork design and labeling guidelines 
  • Support for leading PLM systems

Package Validation

  • Equipment Installation
  • Mold / tool qualification
  • Drawings, specifications and PICs
  • Design validation and stability study 

Digital Transformation & Automation

  • Process automation using the SyntBots automation platform
  • End-to-end digital services through Syntel’s Digital One practice
  • Integration with project management tools for automated tracking and reporting
  • Workflow-driven automation, customized rules and thresholds

SPL Conversion Services for Pharma

  • Label conversion into XML format, R3 to R4 files 
  • Label assistance, authorization and restructuring 
  • Validation for SPL-PLR compliance  
  • NDC labeler code registration, drug listing and content labeling

The Syntel Advantage

  • Decades of experience in labeling, packaging and change management with top medical device, pharma, and biotech companies.
  • Automated QC powered by the SyntBots platform for automated label proofing and change order QC in the PLM system
  • Global footprint for flexibility and scale
  • Innovative factory model to improve speed to market and reduce cost
  • Centralized artwork repository and change management system for better visibility
  • Partnerships with industry-leading labeling, PLM and QMS solution providers
  • Integrated IT & BizOps services to drive improved quality, digital readiness, and increased automation
  • Extensive experience with regulatory agencies like FDA, EMA, PMDA, MHRA, BfArM, and ICMRA

Success Stories

Reducing Label Data Migration Turnaround Time by 35% for a Medical Device Company

The client is a top global medical device company and a worldwide leader in home medical equipment. They were facing issues with data standardization, data duplication and data loss, since past data migrations had been handled manually. They wanted a solution to map data from their existing system to a new one without compromising quality.

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Managed Services Model Helps Save 60% on Label Design, Artwork Management and Proofing

The client is a top global medical device company and a worldwide leader in cardiology and endovascular devices. To keep up with the latest trends, they planned to change their label design and artwork while staying in compliance with regulatory requirements for artwork management. However, they needed to conduct an impact analysis before migrating to the new system.

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