Business Imperatives

  • The Japanese midsize global pharma and biotech company, having collaborated with Freyr for over three years, sought Freyr's expertise once again for comprehensive submission publishing support for Original, LCM, and SPL/SPM submissions.
  • The long-standing partnership between the client and Freyr facilitated the seamless process of the required publishing support.

Objectives

The objective was to implement a scalable hybrid staffing model (onshore and offshore) to provide round-the-clock support. Additionally, the aim was to assist in the first NDS and SPM submission for the Canadian market and to offer effective process consulting by defining, implementing, and maintaining best practices in the publishing process for the US and Canada regions.

Problem Statement

  • The pharma-biotech company faced high attrition rates, leading to unstable resource availability.
  • The company required support for Canada NDS (New Drug Submission) and SPM submissions due to misaligned processes and unclear regulations.
  • Navigating the unclear regulations necessitated expert guidance to avoid delays and compliance issues.

Freyr Solutions and Services

Freyr Solutions and Services
  • Defined the publishing process successfully.
  • Developed a scalable hybrid staffing model that combined onshore and offshore resources, resulting in 24/7 support and cost savings of 50% or greater.
  • Provided process consulting services to define, implement, and maintain best practices in publishing processes, enhancing effectiveness.
  • Executed end-to-end US and Canada submissions.
  • 100% On-Time Submissions.
  • Zero HA Rejections
  • Achieved over 50% cost savings.
  • Enhanced Process Efficiency

Successfully implemented a scalable hybrid staffing model for round-the-clock support, facilitated the company's first NDS and SPM submission in Canada, and provided effective process consulting for US and Canada publishing processes.