Business Imperatives

  • The client, a Japanese pharmaceutical and biotechnology company with a decade-long partnership with Freyr, needed RLP, SLP, and LCM support, as well as SOP creation.
  • They also sought global resource expansion across multiple countries, including Canada, UK, Poland, Netherlands, and Ukraine.

Objectives

The primary objective was to accelerate Regulatory submissions in existing and new markets by leveraging Freyr Solutions' expertise in Regulatory operations, including Publishing Services, Clinical Trial Support (CTS), and data migration activities.

Problem Statement

  • Previously published reports like CSRs and CSR equivalents needed Quality checking to meet health authority requirements.
  • Submissions for Europe lacked attention.
  • Not enough local experts were available at the site.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr offered comprehensive support as an "extended arm" to the client, offering a staffing model for Publishing Services across the US, Germany, and Freyr's India office.
  • Additional Clinical Trial Support (CTS) was offered.
  • Support was provided for Data Migration activities.
  • Assisted in developing assigned Regulatory operations work instructions / SOPs.
  • Supported the testing of a new Publishing tool and participated in Publishing tool User Acceptance Testing (UAT).
  • Assisted in data migration to a new Publishing System.
  • Maintained Publishing metrics/trends for all delivered submissions.
  • Helped navigate submissions as per Health Authority requirements.
  • Achieved a 50% reduction in manual efforts, enhancing efficiency.
  • Ensured high-quality submissions compliant with health authority standards.
  • Successfully expanded Regulatory operations to new markets, ensuring local expertise and compliance.

Freyr’s interventions led to significant improvements in the company's submission processes, resulting in faster and more efficient market entry. The collaboration also bolstered the company's Regulatory compliance and operational efficiency.