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Support Services

Sterile devices - Support ServicesBased on our aim to be a full-service provider to our partners, we have built a large portfolio of supporting activities that facilitate the development of formulations and processes and manufacturing of sterile medical devices in an efficient and cost-effective manner.
 

Regulatory

Sterile devices - Support Services - 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.
 

Logistics

Sterile devices - Support Services - Logistics

Fresenius Product Partnering Medical Devices offers at present 3 distribution options for customers:

  1. Supply of different lot sizes from the distribution centre Bad Hersfeld, Germany
  2. Supply ex factory from Wroclaw, Poland on pallet basis for Europe or container basis world-wide
  3. 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.

 

Procurement of Materials

Sterile devices - Support Services - Procurement of MaterialsOur purchasing staff is experienced in sourcing all the materials needed to manufacture our partners' products. We generally take care of sourcing all excipients and packaging materials according to your product specifications though our qualified-vendor programs. Of course, we can also handle materials purchased by our partners as customer-owned inventory.
 

Life Cycle Management

Being a full-service provider also means that we support our partners throughout all stages of the product life cycle. This means being able to contribute at clinical trial level, to secure supply during (strong) growth of a product, to manufacture a product at full size, and being able to offer additional services during the later stages of the life cycle.