The roots of the pharmaceutical industry as we know it today date back to somewhere around 1850, when local drugstores started selling wholesale medication for the first time. Today, the industry has become not only a giant industry, employing millions of people and generating more than a trillion euros in revenue, but also one of the most regulated ones in the world. And rightly so: with billions of people all over the world using prescription and over the counter drugs on a regular basis, the quality and safety of these medications are vital to the health of the public.
The European Medicines Agency (EMA) , the American Food and Drug Administration (FDA) and many national and international regulations and standards (often referred to as the GxP; Good Laboratory, Clinical, Manufacturing, Distribution, Pharmacovigilance Practices) ensure this safety and quality. And while their importance is unquestionable, their complexity, interpretability and strictness do present a lot of challenges to pharmaceutical companies worldwide. Challenges for which pharma consulting and on-site support by an external partner are often indispensable.
From our offices in Belgium (HQ), the Netherlands, France, Spain, the US, Mexico and Colombia, more than 180 QbD consultants help companies that develop and produce pharmaceuticals to control quality risks during development, production and distribution. We do this by providing staffing and consultancy in the following fields: