Navigating the regulatory labyrinth associated with the creation and use of genetically engineered animals can be a time-consuming, frustrating exercise that draws precious time and resources away from research priorities.
The Exemplar Genetics team provides clients with regulatory support services that cut through the red tape and ensure compliance with guidelines and requirements. Our staff works closely with Food and Drug Administration personnel in order to know the intricacies of current guidelines and understand the impact of regulations under development.
Our staff provides a range of essential regulatory compliance services, including:
Assistance in the filing of an Investigational New Animal Drug (INAD) file and maintenance of such files;
Documents and Protocols necessary to meet FDA requirements;
Training of staff to meet FDA requirements;
Guidance and hands-on services in meeting the reporting requirements of the FDA.
Exemplar Genetics’ compliance assistance services prevent regulatory delays that cost money and stop research projects in their tracks.