Xendo Deutschland, your partner in regulatory affairs...
We are offering regulatory affairs services for customers from pharmaceutical and biotech industry. We have experiences with big pharma as well as with SMEs and start-ups. We understand the needs of headquarters as well as of local affiliates.
In the Spotlight
After xEVMPD we guide through IDMP- and make it easy for you.
Our data management group gives you an overview on the current status and supports you in compiling the necessary information for a timely and compliant data transfer.
More and more companies are switching to worksharing. Will you?
Use of worksharing is but one tool to optimise your maintenance strategy. But an important one, it actually can save time and money. Call in our experts to get it implemented
Press release: Xendo announces management buy-out supported by Sovereign Capital (Leiden, 24 May 2016)
The investment will strengthen the company’s position as a leading consultant and it will have a positive effect on the continuity of business. Current customers will continue to seamlessly enjoy existing services, and Xendo will be able to seek to expand its services and geographical reach, both through organic growth and complementary acquisitions. With a strong track-record as a ‘Buy & Build’ specialist, Sovereign Capital will provide the financial support to grow, develop and expand Xendo.
Under the new ownership the business will continue to operate under its own name. We are also delighted to welcome CFO, Arjen Huijs (previously Jacobs Douwe Egberts) to the current management team.
--> Read more
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 Jun 2015)
Today, Xendo Deutschland GmbH and Brinker Pharmaconsulting have announced their merger. The combination that will arise from this merger will allow Xendo to further expand its presence on the German market offering the full range of consultancy services in the areas of Regulatory Affairs, Pharmacovigilance, Quality Management and Data Management for the pharmaceutical, biotech and medical device industry.
→ more about the merger
Xendo engaged in Biosimilar mAbs (Jun 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 (Jun 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