RegulatoryOur regulatory department has substantial experience in supporting global submissions of our partners´ products in collaboration with the development department. The files are composed efficiently to assure the quickest route to the market. During contract development of research products, the regulatory staff interacts with the project team offering guidance and recommendations based on knowledge of the relevant regulatory regime, including FDA requirements. For commercial manufacturing, regulatory assistance is available to support submissions worldwide.
Fresenius Product Partnering Medical Devices offers at present 3 distribution options for customers:
- Supply of different lot sizes from the distribution centre Bad Hersfeld, Germany
- Supply ex factory from Wroclaw, Poland on pallet basis for Europe or container basis world-wide
- Supply ex factory from Nanchang, China on container basis
Our logistics service offers optimized lean, make-to-order manufacturing and delivery processes, dovetailed with our customers' processes, in order to guarantee constant stock availability with the lowest possible level of tied-up capital.