Manufacturing and Import Authorisation (MIA) and MIA-IMP (Investigational Medicinal Products) Set Up and Licence Application

Our highly experienced Quality team provides quality leadership and QP expertise to support clients seeking to obtain a Manufacturing and Import Authorisation (MIA) in GB or in ROI and has a proven track record of delivery.

We can conduct gap assessments and provide robust project plans.

We can build your Pharmaceutical Quality System in compliance with GMP and aligned with your business model/operations.

We conduct mock inspections to support the preparations, as well as compiling and submitting the application(s) and act as the quality lead during the initial authority inspection.

We also offer Qualified Person (QP) services on a temporary or ongoing basis. This includes naming QP(s) on the Manufacturing and Import Authorisation (MIA) and MIA-IMP (Investigational Medicinal Products), training in-house personnel to become QP(s) and/or supporting during the QP recruitment selection process.

Get in touch with us to find out more