Products combining medical devices and drug products gain more and more prominence on the healthcare market. Often they make things easier for patients and physicians.
Yet in many cases the regulatory evaluation of combination products is everything but simple. The main reason is that for such products the ISO dominated realm of medical devices clashes with the regulatory world of drug products – GMP.
As a consequence from this, Europe and the USA have released various supporting guidelines. However, these guidelines are not in full agreement with each other and up until today remain ambiguous on several questions.
gmp-experts can help You to clarify the regulatory status of Your products, and assist You in setting up an integrated quality management system that meets the various requirements. We can also assist You in product launch, in Europe and the US.