Your batch release (testing) for the EU market is now performed in the UK?
Do you want to prepare for an alternative in case Brexit issues are arising? After Brexit, batch release of (bio)pharmaceuticals for the EU market will not be possible via UK anymore. Our present clients utilize our facility in the heart of Europe (Vienna) to release their products in the EU. We offer the following services:
- Method transfer from your UK facilities to VelaLabs
- Implementation of a formal release process at VelaLabs
- Shipping validation and comparability studies, if needed
- Method validation/revalidation/partial revalidation, as required
- Qualified person services (formal release, regulatory consulting, batch release testing)
- Method lifecycle management for the whole process
- GMP sample storage (liquid nitrogen, - 80°C, - 20°C, 2 - 8°C, 15 - 25°C)
VelaLabs has deep experience with EU batch release of small chemicals and large biologicals, first line products and biosimilars. Many compendial test methods and 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 EU after Brexit!
Contact us at firstname.lastname@example.org for more information!
Do you want to use a single lab for EU and US market release?
We are also listed by the US-FDA!