March 2019: 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 [mailto:firstname.lastname@example.org] 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!