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Tentamus Group GmbH An der Industriebahn 26 13088 Berlin, Germany http://www.tentamus.com
Contact Mr Markus Roucka +43 1 890597911
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VelaLabs dedicated to a Brexit Solution!

VelaLabs - A Tentamus Company

(PresseBox) (Vienna, )
A chaotic Brexit situation will have consequences for release of (bio)pharmaceuticals and impact time to market

Is your batch release (testing) for the EU market now performed in the UK?

Have you made preparations for the event that the UK leaves the EU without a deal?  In a no deal Brexit if you release (bio)pharmaceuticals in the EU, batch release testing will no longer be possible in the UK.  Our current clients use our facility in the heart of Europe (Vienna) to perform batch release of their products to the EU. We also offer the following services:
  • Method transfer to an EU facility at VelaLabs
  • Implementation of EU batch release process at VelaLabs
  • Shipping validation and comparison studies
  • Method validation/revalidation/partial revalidation
  • Qualified Person services (formal release, regulatory consulting, batch release testing)
  • Method lifecycle management for the whole process
  • GMP sample storage (liquid nitrogen, – 80°C, – 65°C, – 20°C, 2 – 8°C, 15 – 25°C)
VelaLabs has extensive experience with EU batch release of both small chemicals, large biologicals, first line products and biosimilars. Many compendial test methods, common physico-chemical and immunological methods including bioassays and high-tech instrumental analytics are available upon request. Our extensive network within the Tentamus Pharma Group enables us to take care of all your batch release needs.

Make sure that your product is immediately available for marketing in the UK and EU after Brexit!

Contact us at office@vela-labs.at for more information!

Do you want to use a single lab for UK, EU and US market release?
We are also listed by the US-FDA!

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Tentamus Group

Tentamus Group GmbH

Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrochemicals, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 52 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.