Business Imperatives

  • A UK-based pharmaceutical company wanted support in the Regulatory and Medical Review of promotional and non-promotional materials. 
  • The client was unaware of the recent ad-promo guidelines. 

Objectives

A UK-based pharmaceutical company wanted to ensure the review of promotional and non-promotional materials and sought support for its submissions.

Problem Statement

  • The client was looking for a reliable Regulatory partner to manage ad-promo imperatives. 
  • The client wanted to complete the Regulatory and Medical review in expedited timelines. 
  • The client was unaware of the recent ad-promo guidelines and wanted support for its submissions. 

Freyr Solutions and Services

Freyr Solutions and Services
  • Conducted Regulatory review of promotional and non-promotional materials. 
  • Provided ad-promo review services. 
  • Performed medical review of promotional and non-promotional materials. 
  • Additional support for other LCM-based submissions and NeeS to eCTD 
  • Freyr experts assisted in product categorization according to ad-promo documents.
  • Ad-promo experts completed the review of all documents. 
  • The experts suggested changes to clients to ensure successful USFDA approval with a right-first-time approach.  
  • Successful ad-promo review adhering to USFDA norms. 
  • Successful submission with Quick TAT 
  • Cost-saving approach 
  • With the assistance of Freyr, the client effectively ensured the comprehensive review of both promotional and non-promotional materials, achieving success in their submission endeavors. 
  • Proper product categorization according to ad-promo documents was successfully done.