Pharma Labeling Compliance: 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, maintaining pharma labeling compliance throughout the process.

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 upholding the practices of pharma labeling compliance.

Freyr has extensive experience in setting up and implementing labeling compliance processes, creating Core Patient Information Leaflet (Core PIL) and auditing the existing labeling setups to ensure Regulatory labeling compliance.


Pharma Labeling Compliance - 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 in 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 the safety & non-safety updates across markets.
  • Creation of Core Patient Information Leaflet (Core PIL).

Pharma Labeling Compliance - Freyr Advantages

  • Resources with in-depth Regulatory knowledge.
  • Expertise in successfully handling global and regional drug labeling compliance for Fortune pharma clients across the globe like the USA, Europe, APAC, MENA, etc.
  • Global Regulatory expertise in covering life sciences organizations, viz. pharma, biotech, and nutrition manufacturers.
  • Highly qualified medical writers with extensive experience in developing compliance labels.
  • In-depth and updated understanding of the global drug labeling changes from multiple Health Authorities such as the USFDA, EMA, TGA, etc.
  • Dedicated Regulatory pharma labeling 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.

Stay Ahead with Reliable Labeling Compliance Solutions!


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