Regulatory Affairs

Global Product Labeling Management

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Labeling is a critical aspect of product life cycle management. With the complex approval procedure for products, content and size of labeling documents in the industry are also strictly regulated. Even after introducing the product into the market, these documents need to be continuously updated.

For change notifications, audit histories, or archiving, legal regulations must be followed. At the same time consistent implementation of the updates must be adopted in all document types, such as patient information leaflets (PIL), core data sheets (CDS) and labels. The format of the documents is regulated by the quality review of documents (QRD) templates for the summary of product characteristics (SmPC). Further requirements for documentation creation result from the need for multiple languages or from the need to convert to XML-based document standards such as the FDA-standard structured product labeling (SPL)/physician’s labeling rule (PLR) for the US package inserts (USPI).

Our team is experienced in e2e labeling artwork management from initiation of the change request for labeling (immediate packaging text and PIL), to implementation of the same for various regulated markets like the US and EU and emerging markets like Latin America, Asia, CIS, and Middle East. The team has expertise in leading the creation of high quality documents supporting changes to the CDS, including the preparation of responses to labeling-related Health Authority queries.

Our labeling experts continuously interact with country specific regulatory hubs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS. When it comes to artwork management, quality control for the artworks is carried out in-house by performing end-to-end examination of labels, inserts etc for administrative, medical and regulatory contents for all the markets.

Our expertise in global label development includes:

  • Creating and maintaining regulatory compliant and up to date global labeling documents (CDS, SmPC, PIL and labeling texts)
  • Labeling updates and amendments submission
  • Preparation of labeling comparisons (for generic product labeling submissions)
  • Artwork preparation (label, secondary packaging like carton, foil, package insert, etc.)
  • Structured Product Labeling (SPL)
  • PIL/Medication guide updates
  • Country specific conversion of labeling

To learn more about Increasing Efficiency, Quality and Compliance via Labeling Automation click here.