PathoGuard Consult consults companies manufacturing biologicals from or with material from human or animal origin for licensure, approval and clinical trial applications by competent authorities.
The focus of consultation is the safety of biologicals regarding transmission of infectious diseases due to the application of the product.
Primarily, complementary approaches have to be implemented in the overall manufacturing process of biologicals: high quality and safety of the starting and raw materials used in the production of biologicals and an effective pathogen reduction capacity of the manufacturing process of these medicinal products or devices.
Consultation service is provided for therapeutic proteins, medical devices and vaccines.