Overview

Product labeling is designed to serve multiple functions across several regions and countries.  On a basic level, national and regional health professional (HP) and patient and consumer labeling communicates information pertaining to the benefits and risks of the product.   It also offers advice on the effective and safe use of the same product.  Biopharmaceutical companies take advantage of the national/regional HP labeling to find out whether they could expect a suspected adverse drug reaction for purposes of expedited reporting to local Regulatory authorities. The exact labeling content of national and regional labeling is generally negotiated between biopharmaceutical companies and Regulatory authorities.

While a lot of countries/ and regions offer a two-tiered labeling system with patient and /consumer information as well as HP labeling, Canada offers a three-tiered system with some detailed  scientific information beyond what is included in the “regular” HP labeling.

 

Freyr Expertise

  • Development of Prescription and Patient Labels for all regions and countries
  • Lead cross‑functional and therapeutic area groups for label development and review
  • Develop/review Medication Guides, Instructions for Use
  • Provide labeling insight and strategy to arrive at consensus
  • Labeling review and compliance
  • Health Authority (HA) interactions and negotiations
  • Support Regulatory agencies requiring labeling information
  • Reference label change monitoring for Generics and Biosimilars
  • Preparation of label comparisons for HA submission
  • Legacy product support for all countries
  • Proofreading and departmental Quality Control (QC)
  • Labeling operations (packaging, bottle labeling and artwork systems)
  • Technical/SPL 
 

Freyr Advantages

  • Resources with in-depth Regulatory knowledge
  • Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients, worldwide
  • Extensive global experience covering diverse Regulatory domains across Pharma
  • Highly qualified medical writers possessing extensive Regulatory experience
  • In-depth and updated understanding of the global drug labeling changes as required by local Regulatory authority bodies
  • Dedicated compliance team tracking the status of data sheets implementation in regional labels
  • Highly experienced labeling professionals