This client had late-stage experience….but not with cell or gene therapies. In a younger industry such as C>, previous agency guidance is not yet as robust as it is for fields that have been around longer. For that reason, sponsors benefit from C>-specific expertise. The client came to Dark Horse to request remediation and resolution of multiple areas for which their original submission was rejected. Due to the time constraints of resubmission, a sense of urgency accompanied getting the product back on track and executing each element of this process on time and with quality as a top priority.
The client successfully completed their post-rejection regulatory agency meeting, allowing for next steps towards resubmission. Dark Horse’s C>-specific project management plan provided necessary clarity and visibility for efficient and effective project remediation along with critical path mapping. Additionally, DHC’s subject matter expertise and technical know-how, combined with project leadership skills, not only prepared the client for their resubmission (along with potential submissions in different regulatory jurisdictions), but also set them up for future successes.
This engagement addressed a wide range of overlapping service areas spanning at least six of DHC’s twelve core capabilities. Among the many services provided by DHC were:
