As you may have already read here, QbD is the reference in consulting in many different life sciences industries (pharma, biotech, cosmetics, medical devices, …) and fields of expertise (quality management, validation, tech transfer, ATMP, …). But what if you suddenly have a specific challenge? How does QbD tackle that on a project management & support level? What can you expect from us once you decide to start a project with Quality by Design?
“We gladly answer that question here.“
First of all, we start by listening very thoroughly to your needs and challenges. Do you want to implement a Quality Management System, or upgrade from ISO 9001 to a higher standard like ISO 13485? Or would you like us to perform all your requalifications? Whatever your request may be, QbD always realises that each specific challenge and client is unique.
That’s why we always start with a visit. That enables us to determine the scope of the project. This visit includes a quick scan, which consists of an interview with different stakeholders, and finally an audit which tells us – and you – to which extent you currently comply with existing norms and procedures. The result is a detailed report, which includes all the steps that are required in order to meet your needs. This report is then translated into a plan with budgets, timings and roles.
If you decide to execute the above mentioned plan with our help, QbD offers two possibilities, depending on the project scope and your own available firepower:
But like we said, each client and each project is unique. So we tailor our project management to your specific needs, ranging from remote advice to the in-house deployment of a large team, or even a hybrid approach.
Whichever road we decide to take, we guarantee you a professional partnership with the best possible consultants that are prepared to go the extra mile for you. So that no matter what, things get done. Without ever forgetting that a big dose of joy always gives you – and us – a head start. Learn more about our corporate ‘JPEG’-values here.