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)
Make sure that your product is immediately available for marketing in the UK and EU after Brexit!
Contact us at email@example.com 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!