Case Study: EU Batch Certification for a Critical Medicinal Product

How MIAS Supported the Client? A Proactive, multipronged approach leveraging the depth of expertise with MIAS

MIAS immediately engaged with both the client and local regulatory authority to propose a pathway to approval:

1. The first action was to compile all the evidence of the sites compliance status and share this with the regulatory body as evidence of the sites capability and suitability to manufacture the product type.
2. This was swiftly followed by MIAS performing an on site audit of the facility, looking specifically at the product type. The findings from this audit were shared with the local regulatory agency.
3. Whilst this was ongoing, MIAS encouraged their client and their site to engage with FDA to arrange an inspection as soon as possible, resulting in an inspection being performed by FDA in Q1 2025.

MIAS then worked with the client to pull together all the data points highlighting the FDA inspection outcome, the outcome of the MIAS audit and the benefit to the patient that the product would provide, and submitted their licence variation.

Final Outcome: Ensuring patients access to the drug without jeopardising quality and safety

On consideration of all the evidence, the local regulatory authority approved the site to be added to the MIAS licence, allowing batch certification to be performed. This ensured that the client was able to launch their product on schedule and start distributing to their patients. This positive outcome was enabled by an unwavering commitment to patient benefit, a pragmatic and proactive approach and clear collaborative communication with the client.