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?
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
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!
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.