Webinar

Biologics Consulting is now offering our clients the opportunity to interrogate their nonclinical safety data and customized consultation through SEND Explorer, the same validated web-based software FDA uses to independently review nonclinical data.  FDA requires SEND data formats to be submitted for independent review; in offering our clients the use of SEND Explorer, this allows for evaluation of nonclinical safety data in an equivalent manner to FDA.

Prior to or in parallel with your FDA submissions, our experienced toxicology and nonclinical experts can support you in:
– Advanced interrogation of your nonclinical safety data through SEND Explorer
– Development of a report summarizing observations with inclusion of graphics, tables and figures unique to SEND Explorer formats for internal use or to incorporate into FDA submissions
– Identification of safety signals and consultation around risks
– Undertaking a mock FDA review
– Drafting and reviewing communications to FDA including formal submission packages and responses for requests for information