All clinical material produced at Vibalogics is manufactured according to an approved manufacturing batch record. We consider the specific needs of live viral products and take into account the Advanced Therapy Medicinal Product (ATMP) guidelines. Upon completion of the manufacture, the batch documentation is completed, reviewed and finally approved by our key personnel.
The batch is then be released by one of our QPs for further manufacture, or clinical use depending on your requirements.
We offer regulatory support to our customers, accompany regulatory authority visits, and help in preparing the CMC section of the investigational new drug application/investigational medicinal product dossier (IND/IMPD).
We would be delighted to discuss your requirements to explain how we can make your task easier by utilizing our expertise.