Business Imperatives

  • The client, wanting to comply with new guidelines from Health Canada approached Freyr for assistance.
  • The requirement was for updating existing labeling documents and creating new ones in alignment with the revised guidelines.

Objectives

To update labeling documents in compliance with new Health Authority (HA) regulations in Canada, across multiple therapeutic areas and products.

Problem Statement

  • The client needed support in various areas, including updating templates, relocating data, creating Patient Medication Information, updating existing labels with safety changes, and handling clarifax requests.
  • The client faced challenges with an outdated labeling template, making it difficult to update according to newer guidelines.
  • The client encountered difficulties in improving the overall organization of all Patient Medication Information, requiring extensive formatting.

Freyr Solutions and Services

Freyr Solutions and Services
  • Updated labeling documents to align with new Health Authority regulations.
  • Conducted frequent quality checks to uphold compliance with HA regulations.
  • Complied with new HA regulations by thoroughly reviewing and integrating the latest requirements.
  • Applied knowledge from a similar past project to understand and implement the new requirements effectively.
  • Started updating labeling documents while also adopting the new format at the same time.
  • Worked on multiple tasks simultaneously, which meant the client didn’t have to make multiple submissions, saving time and making it a cost-effective solution.
  • Held weekly meetings with the client to discuss challenges, address concerns, and provide status updates.
  • Offered fast-track assessment, saving time and costs.
  • Frequent quality checks ensured high-quality standards throughout.
  • Achieved 10-hour TAT per document.
  • 100% right-first-time submission rate
  • Successfully updated labeling documents to comply with new Health Authority (HA) regulations in Canada.
  • Achieved compliance across multiple therapeutic areas and products.
  • Ensured all updated labeling documents met the latest HA standards and requirements.