Overview

Labeling is an interdisciplinary function that serves as the basis on which  prescribing information, advertising and promotional materials for the medication are henceforth created. Biopharmaceutical product labeling is a complex process that involves multiple products and markets for different formulations and dosages. Tracking and harmonization of labeling information, to effectively maintain the safety and efficacy of a drug, is essential for pharmaceutical companies. An effective and robust labeling system should ideally include a defined process, tracking tools and well-trained labeling professionals.  

Freyr has extensive experience in setting up and implementing labeling process, and auditing existing labeling setups.

 

Freyr Expertise

Strategy Consulting:

  • Business/Process/Technology strategy consulting
  • Global label management Standard Operating Procedure (SOP) creation
  • Audit consulting, preparedness assessment and support
  • Label management business process consulting

Technology Consulting & Implementation:

  • Insight-driven, cutting-edge technology consulting
  • Global label management technology development & implementation

Operational Support:

  • Core data sheet authoring, review and approval coordination
  • CDS impact on local labels, local label updates
  • Global label change management
  • Signal impact assessment
  • Manage and update the global label management tool
  • Track potential impact on ROW Labels
  • Establish a process to track changes timely submissions (based on urgent/non-urgent - timelines)
  • Track implementation status
  • Track submission timelines
  • Harmonize safety information
  • Identify internal and external signal detection and innovator label changes (signal management)
  • Assess the safety updates and signals from one region/country and their impact on other regions/countries
  • Assess safety & non-safety updates across markets
 

Freyr Advantages

  • Resources with in-depth Regulatory knowledge
  • Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients across the globe; USA, EUROPE, APAC, MENA etc.
  • Global Regulatory expertise in covering life sciences organizations viz. Pharma, Biotech, and Nutrition manufacturers
  • Highly qualified medical writers possessing extensive Regulatory Labeling experience
  • In-depth and updated understanding of the global drug labeling changes from multiple Health Authorities such as: USFDA, EMA, TGA etc.
  • Dedicated compliance team tracking the status of core and company core data sheet (CDS / CCDS) implementation in regional labels
  • Highly experienced Pharmaceutical, Biotech and Nutrition labeling professionals