All clinical material produced at Vibalogics is manufactured according to an approved manufacturing batch record. Upon completion of the batch manufacture, the batch documentation is completed, reviewed and finally approved by one of our QPs.
The batch can then be released (QP release) for further manufacture, or clinical use depending on the customer’s requirements.
We offer regulatory support to our customers for help in preparing the CMC section of the new drug application. We would be delighted to discuss your requirements and explain how we can make your task easier by utilizing our expertise.