Radio pharma Services

QP Release for Radiopharmaceuticals

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.

MIAS Pharma can provide full life cycle management of your Radiopharma study

OUR APPROACH

Our process begins by supporting the study by optimising the supply chain, here we validate your vendors, if there are any gaps identified, such as missing audits, QTAs or missing providers we will support you to ensure that remedial activities are actioned to ensure minimal disruption to your submission date.

As trials expand into new countries we will work with you to simplify the regulatory process by leveraging our in market specialists to liaise with sponsors and the regulatory agencies as required. In parallel, should trial batch volumes increase we can scale our delivery team to cater for the increased QP release demand.

In line with the novel nature of Radiopharma products MIAS follows a 2 step batch release process, batches are usually shipped to Europe on a Friday, our team will release the product over the weekend and perform the official QP release once material arrives at the trial site on the Monday morning. Testing results are usually delayed and are received 10-15 days post administration, once results are available your designated QP will perform a secondary post release check.

For more information on how the team can help you please email info@miaspharma.com.

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