Intelligent strategies realized via a unique combination of Solem’s execution focused leaders and our global platform of local market resources.

The Challenge

A small sized biotech faced challenges of right sizing and staffing an international regulatory organization. The client was entering new markets and needed a significant amount of support in the prelaunch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce. Enter our on demand regulatory teams….

Solution

Solem was able to meet with the management teams, understand requirements and develop organisational charts, roles and responsibilities that reimagined the client’s regulatory team structure via an outsourced model. With these new operational plans in place, Solem could then reorganize roles and responsibilities of the teams staff the vacancies and bring forward missing expertise via our on–demand network of local market experts. This on demand nature of the team also allowed for continual right sizing of an organization once high work– load periods reduce without losing institutional knowledge.

Results

In the end, the client realized that a tailored organization supported by on demand experts offered a cost effective and efficient way to establish a highly functioning regulatory team. Solem installed a team of 11 people covering most of western Europe in support of the affiliate office needs. In a time of limited regulatory resource availability, our team was in place within 3 weeks and remained in place for over 5 years. Over the course of the 5-year relationship, Solem estimated that we saved our client nearly 35% off the cost of establishing an inhouse regulatory team to service these markets.