Our consultants specialise in providing services at the very core of every product life cycle process: Compliance.
We work with our partners to secure the best talent for you and help you to ensure quality and regulatory compliance, market access to new countries and validation of your quality and software system.
We are proud to have provided operational support on some of the most exciting and industry-leading projects, from band aids to neurotechnology. We help you to help others.
Quality Assurance
Regulatory Affairs
Validation
System Validation (CSV)
Contract
Jason Barrow
Principal Consultant
Luke Morgan
Consultant
Will Godfrey
Billing Manager
Following the acquisition of this business 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.
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, they 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 they're premium service provider and continue to support them with our premium service.
