Regulatory Affairs

Global Product Labeling Management & Technology

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Product labeling is a highly regulated and complex process that can include multiple documents targeted at diverse audiences such as patients, physicians and pharmacists. A product label is very specific and precise in its content, especially with respect to safety data and adverse effects. Furthermore, the label needs to comply with country-specific regulations governing the product.

In addition, changing regulatory requirements and the numerous hand-offs require extensive reviews and proof-reading to ensure that the printed label is error-free. This adds significantly to the cost and time, not to mention the possibility of introducing manual errors. Even after introducing the product into the market, these documents need to be continuously updated.

Our team is experienced in end-to-end labeling operations management and technology 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.

Sciformix’s end-to-end labeling technology platform includes modules for Document Creation & Management, Regulatory Information Management (RIMS), Artwork Management, and Proofing & Comparison. Request a demo.

For labeling operations services, our labeling experts can project manage and oversee all labeling activities for clients – continuously interacting with country specific regulatory hubs to ensure timely implementation of global labeling changes in local product information, and ensuring 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.