Labeling and Artwork Management

Labeling is an important mechanism for communicating safety and benefit-risk information to patients and healthcare professionals. Labeling errors could pose a significant risk to patient safety, resulting in an instance of regulatory non-compliance. This in turn leads to high costs to the company, including those related to product recall and potential fines, ultimately, damaging the brand reputation.
End-to-End labeling is a critical process to launch a product on time, as it encompasses multiple stakeholder groups, from Pharmacovigilance and Regulatory to Artwork and Manufacturing; and spans from signal to patient across markets and geographies.
Navitas Life Sciences has a successful proven track record of managing End-to-End labeling services to support your Global & Local Labeling Change Management as well as Artwork Management.
Global Labeling Management

Global Labeling Management process ensures that your Company Core Data Sheet (CCDS) is created and updated for your drug product. The CCDS is a central resource of safety information for the localized drug product labeling. This internal reference document contains product information applicable to the drug product labeling across the world. Navitas Life sciences provides global labeling services which include:

  • Prepare, maintain and distribute Company Core Data Sheet (CCDS)
  • CCDS can be updated with post-marketing safety data, Health Authority updates, Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, literature references, etc.
  • Prepare executive summary documents to track all changes relevant to CCDS revisions
  • Prepare and maintain Reference Safety Information (RSI)
  • Providing inputs to reference the safety information section in PBRER.
  • Preparation and QC of label documents such as
    • Clinical Overview (CO),
    • Non-Clinical Overview (NCO),
    • Justification Documentation (JD), etc
  • Support for Global Labeling Change Request Management (Tracking, HA Submission and Implementation).
Local Labeling Management

The localized drug product label changes ensures compliance with country-specific regulations and patient safety information for launching the product. Navitas Life sciences provides local labeling services which include:

  • Prepare and maintain
    • Country specific labels and prescribing information
    • Patient Information Leaflets / Medication Guides / Promotional Material
    • Structured Product Labeling (SPL) and Physician Labeling Rule (PLR)
    • Basic Patient Leaflet (BPL)
    • Medication Guides and Instructions for Use
  • Support Health Authorities (HA) on
    • Interactions and negotiations
    • Labeling queries
  • Collaborate cross-functionally with therapeutic groups for label development & review
  • Implementing the CCDS updates into the country specific labels
  • Comparative analysis of local label content
  • Proofreading and Quality Control (QC)
  • Local label safety alignment with reference label
  • Comparison of Labels for HA submissions
Artwork management

Artwork management is required to market your products for compliance with local regulations. Navitas Life Sciences provides Labeling and Artwork services for Pharmaceutical and Medical Devices delivering cost effective and compliant artwork solutions. We provide Artwork Management services which include:

  • Creative Artwork Design from Development to Life Cycle Management of labeling
    • Creation of die line / templates for labeling creation
    • Creation and maintenance of Graphic Design labeling components (labels, cartons, blister packs, pouches, package inserts, etc)
    • Multi-language labeling creation
    • Effective Proof reading / QC check process
  • Support labeling change requests for
    • All types of launches as per launch strategy
    • Labeling text modifications
    • Submission mock-ups
    • Product line extensions,
    • Manufacturing / Packaging Site changes
    • Regulatory / legal changes,
    • Serialisation
  • Coordination with different stakeholders for artwork creation and approvals
  • Color standard review and approval
  • Liaise with printer for final printing of packaging materials