EUROPEAN PRODUCT COMPLIANCE PROJECT
Client: Major Global Pharma Company
Project Value: £8.1 million
A major pharmaceutical company, based in Europe, had a large product compliance project where they wanted to bring all their European-registered licenses into compliance with the current manufacturing site practices.
The company had also undergone a period of mergers and acquisitions and felt that it was important that their manufacturing practices complied with their licences.
The sheer scale of the project meant that a dedicated team of regulatory affairs specialists would have to be brought in to work on the project for 2-3 years.
The client approached Pharmalink Consulting to provide a team of regulatory affairs consultants to completely control the regulatory side of the project.