Business Imperatives

  • The company provides a wide range of products and services to support R&D in the life sciences and other related fields.
  • The customer is in the process of transitioning from compliance with In Vitro Diagnostic Directive (IVDD 98/79/EC) to In Vitro Diagnostic Regulation (IVDR 2017/746) for their IVD products.

Objectives

Freyr understands that the customer is currently in the process of transitioning, and thus, needs additional external support from Freyr’s Regulatory team across multiple areas to attain overall compliance with IVDR Regulatory requirements.

Problem Statement

  • The customer has a large portfolio of products, and thus, it was difficult to meet the IVDR timelines for all the products with their current capacity.
  • Extensive data mining was required for developing deliverables for the listed products.
  • New products were added into scope intermittently throughout the project delivery.
  • The stakeholders are located across different geographies and time zones.

Freyr Solutions and Services

Freyr Solutions and Services
  • Given the project complexity, it was essential to have an effective execution strategy, which had to be agile and flexible to accommodate the ad-hoc addition of products in scope.
  • Detailed preliminary due diligence was carried out and the products were grouped into different buckets.
  • A dedicated team was formed; eight (08) sub-teams, with four (04) members in each, was carved out and product buckets were assigned to them.
  • Freyr performed extensive data mining for the products, as per the requirements.
  • The project was delivered in 20 waves.
  • The deliverables provided were 200+ CPRs, 190+ SOTA, and 40+ APR.

Robust Deliverables:

  • 215 CPRs
  • 159 SVR SOTA
  • 44 APR
  • On-time delivery of all deliverables

Efficient Execution:

  • Approximately 30% reduction in project costs.
  • Agile and flexible execution of strategy to accommodate the ad-hoc addition of products in scope.

A Transparent and Compliant Framework:

  • Compliance with IVDR ahead of timelines.
  • Transparency in team structure and project handling.

Resource Management:

  • A dedicated team spread across geographies for round-the-clock availability.
  • Upscale/downscale of resources, as per the requirements.
  • Transparency in the entire project process, while maintaining seamless communication with the customer.
  • An agile execution strategy, with a dedicated team of experts.
  • 30% reduction in project costs.
  • Leverage to ZOTERO, a referencing software tool.
  • Data management excellence.