Following the acquisition of Xenios AG by Fresenius Medical Care, we were approached with a project requirement to expand their market approvals of their existing class III heart and lung therapies to include the FDA. The objective was to ensure their organisation went through an FDA Readiness program, upgrading and implementing new documentation and submissions, to achieve successful FDA approval, across all 4 of their German locations.
Working closely with the QA, Regulatory and Validation department ,we supported an initial GAP analysis to understand the biggest pain points and gaps to prioritise the tasks in the project. We then assessed the internal capabilities and manpower to understand how we can best support them with highly qualified experts for the respective tasks. Together we defined the project specifications and managed the whole sourcing and talent delivery process, including first initial face to face or virtual interviews, references from previous FDA readiness projects and a detailed shortlist for our client for a lean hiring process.
With the help of our bespoke and thorough delivery processes, Xenios secured five highly qualified experts within 10 days. The project duration was 1.5 years, whereby we evaluated additional requirements and managed a flexible workforce to deliver talent and expertise at various stages of the programme.
The project outcomes were always delivered within set deadlines. All audits were delivered successfully; resulting in adoption of their products into the US markets.
We received very positive references regarding our services and continued support, thus are valued as Xenios' premium service provider and continue to support them with our premium service.