An India-based fast growing integrated Pharma company for its established medicinal products was aiming at 50 PDE evaluations. As per the need for stringent evaluations in quick timelines, gathering required toxicological information posed a great difficulty especially with the old MSDS provided. In addition, scenarios of exposures were entirely different.

Read through this case to decode how Freyr continued with process streamlining, end-to-end toxicological gap analysis and health based risk assessment for the EMA compliant PDE evaluation and documentation