VelaLabs – FDA audit with focus on clinical development of a Biosimilar (GCLP)

Unannounced US-FDA Audit in August 2015

In August 2015, US-FDA conducted a clinical audit due to the clinical biosimilar program of VelaLabs. The product of interest was previously marketed in the EU and Canada and is now on the way to get its approval in the USA.

After a full week of document review, data evaluation and discussion, VelaLabs successfully passed all FDA requirements.

Info: VelaLabs is performing product release testing for the biosimilar market in the EU 

Link to Analytics.