Pharmaceutical and medical device companies often rely on external suppliers such as Q1 Scientific for the development and production of various components of their products. To ensure the safety and quality of their products, pharmaceutical companies or medical device companies with combination products often require their suppliers to complete establishment registration with the FDA.
The rapidly accelerating demand for combination products continues to drive technological advances in merging product types. However, the convergence of pharmaceuticals with medical devices brings a host of new challenges in stability studies and storage. At a high level the FDA defines combination products as “therapeutic and diagnostic products that combine drugs, devices, and/or biological … Continued
Multual Recognition Agreement (MRA) HPRA / Ireland has been listed by the US Food and Drug Administration (FDA) as part of the mutual recognition agreement between the EU and the US
“A site that carries out storage of stability samples is not required to hold a GMP certificate for this activity in Ireland”