Labelling Management

Labelling is an important aspect of the marketing of a product. Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used with safety and efficacy.

However, regulatory labeling compliance requirements can differ across regions and new regulations are routinely being introduced to update labeling documents.

Xplore Healthcare team provides assistance in following labelling activities:
  • Labelling Management – Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet & SPC.
  • Side by Side comparison of Labels in reference to innovator
  • Structured Product Labelling (SPL) for US.
  • Regulatory Operations Support in submission management planning and publishing strategy, Assist in Document Level (DLP) and Submission Level Publishing (SLP).
  • Support industry to harmonize countries wise electronic submissions format, Multi stage review by using effective quality review checklist
  • Structured Product Labelling (SPL)
  • Expertise in conversion of FDA compliant & validated SPL files (XML)
  •  NDC Labeler Code / Establishment Registration / GDUFA Identification
  •  Drug Labelling (Prescription, OTC and Compounded)
  • Life-cycle management of SPL (version and set id management)
  •  SPL validation as per FDA compliant and specification (zero error)