Author Archives: Ron Hinkel

Anticipated Regulatory Changes Affecting Biopharmaceutical Testing

It is important to ensure that testing services meet applicable regulatory standards necessary to support investigational new drug (IND) applications, the clinical development life cycle, and commercialization. However, monitoring and — when possible — anticipating the ever-changing regulatory landscape is a challenge. Yet, the failure to do so can negatively affect both the cost and time needed to move a product from development through to commercialization. This article describes BioReliance’s position concerning anticipated regulatory changes over the next three to…