Confidence Beyond Compliance

Health authorities around the world mandate drug companies with various Drug labeling formats and standards. Product Labeling is a complex process that is highly affected by a constantly changing regulatory environment. A mistake in product labeling or bad readability can come at a high cost, which is why often times companies seek external support. In order to adhere to the legislation, product information related to manufacturing, safety and efficacy included in product labels, should be controlled by maintaining a central Company Core Data Sheet (CCDS). We provide end-to-end support for the entire labeling process, which includes managing global and regional requirements, compliance, technology requirements, as well as proof-reading and translation services.

Our services include:

  • Development and maintenance of global regulatory product information
  • Preparation of supporting documentation – clinical and non-clinical overviews, expert statements
  • Alignment of CCDS with regional labels and vice versa
  • CCDS change descriptions
  • Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and label for marketing authorization applications
  • Literature searches
  • Communications with health authorities / agencies
  • Provision of labeling repository
  • Tracking and monitoring of current status and key milestones
  • Artwork management
  • Translation services
  • Proof-reading and readability testing
  • Quality control

PharmaLex experts are highly qualified in medical writing of data sheets implementation in local labels, review and suggest the changes to the data sheets and write the clinical overviews for submission to the Health Authorities / Agencies.

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