MIAS Pharma has carried a number of clinical Radiopharma projects over the past 5 years for both EU & UK markets. We specialise in taking away the barriers usually associated with entering the EU market. Our MIA (Manufacturing Licence) allows our QP team to carry out a Quality release from Ireland and your product go from a third country straight to your clinical sites without impediment.
As part of our offering, we can qualify your supply chain against EU GMP, support your IMPD for Europe by providing a QP declaration, organise customs clearance & importation services as well as deal with local regulatory agencies on your behalf (ie France) to ensure that trial sponsors and CROs can carry out your study in a compliant time efficient and cost effective way.
Outside of QP release MIAS can provide full life cycle management of your Radiopharma study and can also support you in the transition through clinical phases to final commercialisation via our partner network. We also encourage and work with our customers to build their internal capabilities so they can scale their team to bring EU technical capabilities in house. We initially can support you to train or bring in your own QP / Contractor to QP release on your behalf under the MIAS MIA, when the time is right we can then support your team to get their own MIA (be it commercial or IMP) and transition your company into becoming a standalone EU entity.
For more information on how the team can help you please contact us.