A US biotechnology company asked us to review the Chemistry, Manufacturing and Controls (CMC) components of a dossier against EU requirements. The dossier had previously been submitted to the Food and Drug Administration (FDA) and European Medicines Agency (EMA). It had received approval from the FDA but had been rejected by the EMA.
The client required the review and subsequent guidance for resolution within a one-month period.
The work centred on reviewing the quality overall summary (QOS) and Module 3 to identify and highlight deficiencies against EU requirements. This review then formed the basis of a written report summarising key issues and providing guidance on overcoming them.
The TRAC solution
Jonathan Trethowan, TRAC’s regulatory director was the client’s main contact. Jonathan has extensive CMC expertise and was assisted by regulatory affairs consultants with a good working knowledge of FDA and EMA requirements. A long-serving TRAC associate with specialist API experience completed the team. She was brought in to conduct the gap analysis on the API sections.
The work was carried out remotely with regular telephone conferences that took into account the US-based client’s time difference. Meetings were held with the client at the start and conclusion of the project and the TRAC team had regular weekly meetings with the product experts.
The TRAC team was able to deliver this project on time and on budget. The final report detailed deficiencies along with the clear remedial actions that would fulfill EMA expectations and result in a successful submission.
Key to this success was TRAC’s facility for being able to put together the right mix of skill and experience at short notice. The regulatory affairs consultants had the relevant European knowledge and expertise as well as sound working relationships with each other and the agencies involved.
Feedback was very positive and there is now the possibility of future work from this client.