Business Imperatives

  • An American biotechnology company approached Freyr for a Medical Review of promotional and non-promotional materials. 
  • The client sought assistance from Freyr in reviewing and submitting promotional material to Health Canada. 
  • The client sought Freyr's support due to their lack of awareness regarding the latest ad-promo guidelines. 

Objectives

To assist a vaccine-producing biotech firm with the Regulatory and medical review of both promotional and non-promotional materials for submission to Health Canada for the Canadian market.

Problem Statement

  • The client, focused on developing vaccines for serious infectious diseases, had struggled with advertising and promotional challenges for a long period. 
  • The client was unaware of the process of getting the promotional material reviewed before Regulatory submission. 

Freyr Solutions and Services

 Freyr Solutions and Services
  • Freyr offered extensive support for Ad-promo materials for their approval from Health Canada. 
  • Freyr helped clients understand recent ad-promo trends in Canada. 
  • Acted as liaison for all ad-promo-related queries on behalf of the client. 
  • Ensured zero errors through the eCTD submissions portal. 
  • Undertook the reference review, formatting, and approval process swiftly to ensure uniformity across documents. 
  • Freyr experts enhanced clarity and accuracy in product categorization according to ad-promo documents. 
  • To ensure successful Health Canada approval, experts suggested several changes to clients during the rewriting process. 
  • Right-first-time submission was ensured by engaging in peer-review cycles where documents underwent thorough examination and feedback. 
  • Error-free ad-promo review and submissions. 
  • One-stop solution for ad-promo-related imperatives. 
  • Offered multiple review cycles to the client. 

Completed the medical review of promotional and non-promotional materials, ensuring accuracy with regulations and proper product categorization according to ad-promo documents through a scientific process.