ABL Europe has experience supporting clients with GMP supply of viral vectors for use in phase 3 pivotal efficacy trials. Regulatory authorities worldwide require sponsors to expand their CMC section content, as a part of their product licensure applications, for e.g. Marketing Authorization Application (MAA), Biologics License Application (BLA).
How can we help you?
ABL Europe is actively preparing for preapproval inspection in 2021 and is expanding capacity availability to meet the increased demand. At the current time, approved / licensed products are not yet manufactured by ABL.