Regulatory Information

Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow. The ever-changing sphere of HA regulations makes it arduous to keep track and adapt at the same pace.

Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming. Reducing those procedural burdens to streamline the processes and in order to provide the physicians the flexibility to access investigational drugs and biologics, the US Food and Drug Administration (US FDA), on June 2, 2016 has released 3 final guidance documents.