Services

Services2018-11-09T11:31:59+00:00

QP Batch Release

In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to Batch Release a drug product (Batch Disposition) the QP is required to be on a licence known as an MIA (Manufacturer’s/ Importation Authorisation). In 90% of cases our clients then opt to go the Contract MIAS QP route (Pay As You Go model) rather that recruiting their own personnel for Batch Release. However, if a client does have their own QP the option is available to add them to the relevant MIAS MIA for Batch Disposition to occur.

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QP Declarations

MIAS assists companies with their MAA application by providing a QP Declaration to substantiate their submission. As MIAS holds MIA Licences we are often named both as Site of Batch Release and for Product Defects and Recalls.

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Supply Chain Oversight

Pharmaceutical supply chains often extend across multiple transportation routes and regulatory jurisdictions. Without Supply Chain Oversight these complex supply chains present challenges in terms of maintaining quality of medicinal product in-transit and the increasing global risk of Falsified Medicines entering the supply chain.

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Virtual Quality Department

MIAS Pharma has a team of experts that can provide expert Quality and Compliance support services to your organisation from both high-level QA strategic planning and decision making through to the provision of a Virtual Quality Department service across your pharmaceutical product supply chain.

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Supply Chain Mapping

The EU currently consists of 28-Member States; each has its own market nuances for transportation and distribution of pharmaceutical materials that will need to be addressed. There is significant complexity to navigate in determining a commercialisation strategy for the EU, supply chain mapping and optimisation of the supply chain structure to facilitate GxP compliance can deliver significant financial savings over the life cycle of a product.

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MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Ireland

Phone: +353 (01) 846 3605

Web: MIAS Pharma