Vigilex Xendo DeutschlandXendo Deutschland

News

 DIA/Regulatory challenges part I-The future of RA (Hamburg, Apr 2016)

 What has changed in RA in the recent years? Where do we head to and what requirements will become important for RA experts?
--> Visit the Xendo booth I.5 at the DIA in Hamburg on April 6-8
for a free copy of a publication on the topic “Quo Vadis regulatory affairs?”

 

Meet us at TOPRA 12-14 Oct 2015 (Berlin, Oct 2015)

We are looking forward to discuss, how you can efficiently work with Sharepoint in RA. Or our second topic, the Strategic Maintenance Partnership and how to work with Xendo.

--> visit us at Booth no. 11 

  

Workshop on Regulatory Affairs for biopharmaceutical products (Berlin, 22 Sep 2016)

The regional biotech-network BBB is hosting a Regulatory Workshop on September 22nd, 2016, in Berlin. Xendo-experts will present their views and experiences how development costs can be minimized, if regulatory requirements are considered. You can find further details on the → BBB website or in the attached → programme.

 

Xendo Acquires Brinker Pharmaconsulting
(Berlin, 12 June 2015)

Brinker Pharmaconsulting and Xendo Deutschland GmbH have decided to merge and signed the contracts on 12 June 2015.

The decision to merge was motivated by the belief that the combined company can respond better to your needs than the two companies separately. Thus, you can benefit from a larger service portfolio. From now on, we will always have the right expert at hand for Data Management, Quality Management, Regulatory Affairs and Pharmacovigilance.  

Also we are asked to take over bigger projects, like global dossier harmonisations, which we execute more efficiently in a bigger team. More and more customers are outsourcing business processes, such as variation management for certain countries and products. Developing robust solutions to address these needs is greatly facilitated by combining our expertise and experience. 

The merger foresees that Brinker Pharmaconsulting is converted into Brinker Pharma GmbH of which Xendo Deutschland holds all shares. Annette Brinker will remain responsible for Brinker Pharma GmbH as a Managing Director. 

Please see attached the full press release for further information. 

 

Xendo engaged in Biosimilar mAbs (06/2015)

This month, Xendo and Biosana agreed on cooperation in Biosana`s development activities. Xendo focusses on a fast time-to-market from RA perspective. 

We will ensure, that regulatory requirements are fully considered, from development to dossier submission. 
more about new applications

 

1 Year RegChange (06/2015)

After the first year, our app is installed on more than 500 mobile devices. We have users from all around the world, including officers of the Health Authorities. In addition, we could win the German Pharmaceutical Association (BPI) as a sponsor. We are ensuring the accuracy of the content on a monthly basis (e.g. article 5 updates). → more about our tools