Register For News

Background

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.

Solution

Assion were able to meet with the client management teams to understand their requirements and objectives before developing organizational charts, roles and responsibilities that re-imagined the clients regulatory team structure via an outsourced model.

With these new operational plans in place, it was then possible to reorganise the roles and responsibilities of the teams and to staff the vacancies whilst also bringing forward vital missing expertise via an on-demand network of local market experts. The on-demand nature of the team also allowed for continual rightsizing of an organization once high workload periods reduced, without losing any institutional knowledge.

Results

In the end, the client acknowledged that a tailored organization supported by on demand experts offered a cost effective and efficient way to establish a high functioning, high expertise, regulatory team. A team of 11 people was placed in order to cover most of Western Europe to support the affiliate office needs. In a time of limited regulatory resource availability, the newly generated team was in place within three weeks and remained in place for over 5 years. Over the course of the five year relationship, it is estimated that Assion saved our client almost 35% of the costs of establishing an inhouse regulatory team to service these markets.