Regulatory Strategy

Before a product goes into clinical trials (or in some cases before pre-clinical testing programmes are devised) it is important to understand the regulatory landscape and any relevant precedents pertinent to an asset. Regulatory guidance in the form of guidelines, and emerging policies and personal knowledge of these areas can build a framework for the overall development plan.

Armed with this data a company can determine the most appropriate route to market for their product. In addition, a complete overview of nonclinical, technical, and clinical testing required for approval can be gathered.  Once a Regulatory Strategy is defined a company can be prepared to face the challenges and hurdles, both scientific and financial, in developing an asset.

Sharp Regulatory can help with all aspects of Regulatory Strategy, including changing the plan as new data comes to light throughout asset development.