Business Imperatives

  • The client had been looking for end-to-end labeling support for the US region and for some countries in the RoW region.
  • With Freyr as the client’s partner of choice, the client sought end-to-end labeling support.

Objectives

The objective was to ensure complete labeling assistance for numerous antibiotic products from a European pharmaceutical company. This assistance extended across regions, including both the US and RoW regions.

Problem Statement

  • The client lacked in-house Regulatory expertise.
  • The volume of work was substantial, with two regions included in scope.
  • The client had been seeking a single partner capable of handling multiple countries within the two regions (US& RoW).

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr's team worked closely with the client, regularly communicating via calls and follow-up emails to gain a thorough understanding of their needs and ensure that all labeling components complied with relevant regulations and met timelines.
  • Freyr began by creating ANDA labeling components, (RLD vs PI side-by-side comparison, artworks, and artwork annotations) in accordance with FDA Regulatory requirements for the US region and the specified countries in the RoW region.
  • Subsequently, Freyr reviewed all existing ANDA labeling components for both regions in scope.
  • Rigorous and multiple-level quality checks enabled the provision of right-first-time documents that were submission-ready.
  • Achieved 100% right-first-time submissions.
  • Eliminated "Refuse to File" instances.
  • Ensured quick TAT for labeling document preparation.
  • Choosing a single vendor reduced overheads and saved costs.
  • Freyr's close collaboration with the client ensured compliant labeling components meeting regulations and timelines. The team started with ANDA labeling creation and review; rigorous quality checks delivered submission-ready documents. This single partnership streamlined operations by addressing the client's Regulatory expertise gap and efficiently managing the workload across two regions.