Business Imperatives

  • Support was required for partial change applications, renewals, variations, supplemental CMC, and labeling safety.
  • Freyr had already provided support for PV and access to local resources in Japan and China, prompting the client to seek additional assistance for Publishing and Submissions.

Objectives

The client required assistance with partial change applications, renewals, variations, supplemental CMC, and labeling safety for their therapeutic segment focused on Gynecological products, catering to women's health needs.

Problem Statement

  • The development of Standard Operating Procedures (SOPs) and the creation of work instructions involved a substantial process, including planning, publishing, and printing created a challenge in the new region.
  • Accepting submissions in the local language as mandated by the respective Health Authorities (HA) made finding local experts appear daunting.
  • Reliance on paper-based submissions exacerbated operational inefficiencies and added to the overall complexity.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr provided support for the client's needs in partial change applications, renewals, variations, supplemental CMC, and labeling safety.
  • Comprehensive end-to-end submission services, encompassing planning, publishing, and printing in paper format, were rendered.
  • Freyr completed over 40 submissions in China and Japan.
  • Reviewed client requirements for PV-related activities, focusing on partial change applications, renewals, variations, supplemental CMC, and labeling safety.
  • Specified support for China and Japan in the therapeutic segment of Gynae products.
  • Created a tailored strategy for Regulatory submissions in both regions and completed over 40 submissions in China, ensuring compliance and accuracy.
  • Provided training for additional resources to maintain quality standards.
  • Huge volumes of submissions for China were efficiently managed.
  • Successfully achieved 100% compliance with Key Performance Indicators (KPIs) and Service Level Agreements (SLAs).
  • Quick TAT was ensured for 5 submissions, completed in less than a day, including planning and publishing.

Freyr successfully provided comprehensive support to the client for partial change applications, renewals, variations, supplemental CMC, and labeling safety, specifically for their therapeutic segment focused on Gynecological products, addressing women's health needs, executed over 40 submissions in China, meeting Regulatory requirements and client expectations.