The Situation
- An established European pharmaceutical company was establishing a US subsidiary through the purchase of an existing portfolio of approved products.
- The company engaged EVERSANA to assist in the transfer of ownership of the acquired products and to act as their Head of Regulatory and Head of Quality for the US business.
- Client challenges included aggressive timelines with no internal expertise with US FDA requirements to support the project.
The Solution
- EVERSANA’s Regulatory Consulting worked closely with the client team to set up and register the US business with FDA, secure the asset documentation and prepare transfer of ownership submissions for several products acquired from another company.
- We worked with the selling company to iron out a timeline for the transfer of all needed documentation and submission of the FDA notifications.
- EVERSANA quickly set up a team comprised of regulatory, quality, and quality management system professionals to provide the manpower and expertise needed to support the acquired products and maintain a compliant state without affect the supply of these products to the market.
- The team acted as an extension of the client’s very lean team. Due to the absence of adequate resources available at the client, EVERSANA acted as their regulatory and quality departments to stand up the business and allow for continued marketing of the acquired products.
- EVERSANA worked with the various business units, including alignment with operations, to support the strategy. Successful interface with the client’s CMOs prevented supply interruption during transit issues.
The Results
- On-time submission of the ownership transfers, which delighted the client because there was no disruption in achieving their organizational objectives.
- A compliant quality management system was set up and implemented allowing for timely batch releases and product quality complaint handling.
- Successful liaison with FDA to ensure lifecycle maintenance of applications.