We were able to create a clear pathway across Europe whilst saving 30% of the budget along the way.

The Challenge

We were approach by a US biopharmaceutical organization when they had filed for regulatory approval in Europe. The organization focused on the development of novel drugs to treat chronic liver diseases and intestinal disorders. Their goal was to commercialize their product outside the US.

We were asked to solve the complicated jigsaw puzzle of local requirements that pave the journey within Europe. Due to the fact that each European country has specific levels of local representation, laws and regulations.

Solution

Working to an agreed NDA, we kick started the project by facilitating meetings with key stakeholders. We needed to establish their current situation and challenges they were facing. They told us of their future plans and aspirations. We had to understand what was required to be able to support our delivery.

Once the regulatory pathway was mapped by the market, we prepared an organizational solution through our corporate platform. This allowed us to create a clear, efficient and effective path across functions and countries.

Works included:

• interim management
• local market representation to the respective authorities
• restructuring of a commercial plan to target more effective channels
• a strategy for registration, licensing, pricing and reimbursement
• and other tailored commercialization workstreams specific for each country

This was enabled by the fact that we have representatives and partners across Europe. Our client then focussed on other areas of the journey while the granular national requirements were solved locally by us.

Results

Our integrated platform was essential in providing our client with the best of class in regulatory support from each country. This was managed whilst using only 70% of the anticipated budget for organic development. Creating huge savings for the client. We were also working ahead of the previousy agreed launch schedule. Over the duration of the project we were ultimately able to support as their local market affiliate level regulatory organization, covering 14 western EU countries for 5 years.

We have a detailed and very familiar understanding of each country’s nuances when it comes to local representation and regulations within the Life Science industry. This expertise meant we were able to tailor our bespoke  solution to this specific biopharma to meet each new market’s requirements.

Get in touch

If you’d like to better understand how we can help you with a clear pathway into Europe when regulating and commercializing your novel drugs, contact us today at info@solemglobal.com