Lyophilization Cycle Development of Pharmaceutical Products

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This extremely topical webinar addresses the challenge that the complex European Medical Device Regulation (MDR) poses for the entire industry, with a special focus on drug combination products and the requirements of Article 117.

Join Heinrich Martens, Vice Regulatory Affairs, Fresenius Kabi and Jonas Orf, Junior Key Account Manager, Fresenius Kabi as they shed light on the new requirements of MDR including stricter pre-market control, oversight of notified bodies, inclusion of products without medical purpose and rules on clinical data and clinical investigations.

They also provide an introduction to the drug combination ‘world’ within the context of MDR Article 117, the role of the Notified Body, fulfilment of the General Safety and Performance Requirements (GSPRs) and responsibilities and obligations of the manufacturer(s).

“In the MDD world that we had in the past, we had the essential requirements, which were similar to the GSPRs, but there was never anything about a Notified Body opinion, an additional approval step for the device that was required for a drug combination submission to the authority,” says Martens. “Which is totally different when you look now into Article 117.”

By watching this webinar, you will understand:
What is a combination product

The meaning of Article 117

The role and task of the Notified Body

Manufacturer responsibilities

Evidence and fulfilment of the GSPRs

Notified Body opinion

As a specialist in diluent solutions Fresenius Kabi is the right partner for you. We offer solutions, that fit together with your needs. Find out more about our diluent production in this video

Find out about our Contract Manufacturing and fill- and finishing services for sterile pharmaceuticals and medical devices. We offer different containers in various sizes like pre-filled syringes, ampoules, vials, bottles and IV-bags.

In our latest INSIGHT edition we introduce our three US facilities and our new US team.

This INSIGHT edition sheds light on our production site in Halden, Norway, our IV-bag capabilities and our medical devices expertise.