Business Imperatives

  • The client was searching for a Regulatory expert to support them in providing end-to-end labeling services.

Objectives

The objective was to provide comprehensive end-to-end labeling support tailored to the US region, focusing on generics across multiple therapeutic areas and products.

Problem Statement

  • The client was facing challenges with the management of the active products portfolio, which consisted mostly of complex generic products
  • In-house Regulatory expertise was lacking due to which the client needed a partner for support.
  • The client was facing issues in handling the HA queries, hence required support from Regulatory experts to provide Regulatory input and respond to Health Authority (HA) queries.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr offered high-end support for Labeling activities, encompassing initial submissions and lifecycle management activities.
  • Freyr assisted the client in managing Health Authority (HA) queries effectively.
  • Freyr supported to the client in SPL activities, artwork updates, and publishing activities.
  • Achieved 100% right-first-time submissions, ensuring accuracy and quality in labeling activities.
  • Attained an exceptional response rate to Health Authority (HA) queries, demonstrating thoroughness and effectiveness in query management.
  • Maintained quick turnaround times (TAT) for all activities, ensuring timely completion of tasks.
  • A thorough and customized support system for labeling needs from start to finish was provided to the client, specifically designed to meet the demands of the US market. This included a detailed approach, particularly focused on complex generic products across a wide range of therapeutic areas.