Medium-sized Pharmaceutical company.

Our client required Regulatory and Clinical support with a new drug submission (NDS) to a Health Authority for a small molecule oncology treatment.

Further support was requested to prepare the client’s team for Agency meetings. This included advising on a regulatory strategy, facilitating additional meetings and leading negotiations with the Authority.

Our work here commenced with a gap analysis to provide documentation relating to Canadian regulatory requirements.

We then assisted in the preparation of Module 1 documents, including country-specific forms, environmental assessments, labels, CSBE and data sets.

Following this, we reviewed the contents of Modules 2.5 and 2.7 and the QOS, before conducting a full review of Modules 3 and 5 to ensure compliance with the Health Agency requirements.

With this completed, we prepared the team for meetings and actively participated in responses to questions and label negotiations.

Our client successfully gained the endorsement of their plan and submitted the initial NDS in accordance with their required timelines.