Commercial QP & Clinical QP Solutions for EUadmin2023-11-20T11:31:19+00:00
Discover how MIAS Pharma can help your business grow.
Our Services Cover Diverse Product Markets.
EU 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.
In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP) who is named on an MIA (Manufacturer’s/ Importation Authorisation).
EU 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 certify a batch of a drug product the QP is required to be named on a licence known as an MIA (Manufacturer’s/ Importation Authorisation).
Virtual Quality Assurance
Working with our client’s Quality, Operations, Supply Chain and Regulatory teams to map the physical and financial ownership flow of materials and products in your supply chain, we identify all 3rd parties involved; we evaluate their licence status; we determine if their Quality standards are adequate and we support maintenance of those Quality standards to support QP services. We provide all QP services from API declarations to routine batch disposition
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.
Supply Chain Mapping
MIAS facilitates experts on EU Law and Taxation to work with our client to define the ideal EU Entity structure from a legal and financial perspective to maximise tax benefits and R&D rebates in Europe for current and future product lines.
“To accelerate the availability of medicines to patients within the EU.”
MIAS Pharma provides a licensing framework to enable pharmaceutical importation and batch certification.
Supply chain oversight partner.
To be the supply chain oversight partner of choice for International Pharma /Biopharma companies for product release into Europe.