About

MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. Customers are small to medium Pharma / Bio-Pharma companies that look to enter the EU market but do not have required Manufacturing and Importation licence or the Quality/Regulator expertise to comply with complex EU regulations. MIAS Pharma delivers two main solutions: 1. A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace) 2. Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market. MIAS Pharma also provide oversight of: - European Qualified Person (QP) services - Regulatory compliance of manufacturing activities - Regulatory compliance of Repackaging / Relabeling services - Regulatory compliance of Shipment and Transportation activities - Compliance with responsibilities as a Market Authorisation Holder (MAH) MIAS operates in a hub and spoke model with a core group of MIAS employee being able to rely on a group of associated to flex up/down capacity depending on clients’ requirements. About MIAS Pharma Ltd MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. Primary customers are small to medium Pharma / Bio-Pharma companies that look to enter the EU market but do not have required Manufacturing and Importation licence or the Quality/Regulator expertise to comply with complex EU / UK regulations. In recent times MIAS also supports CMOs, CROs, Packaging companies and Testing companies QP solutions to take the burden off internal resources. MIAS Pharma delivers two main solutions: 1. A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace) 2. Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market. MIAS Pharma also provides: 1. European & UK Qualified Person (QP & QA) services 2. QP Audit programs 3. QMS Design: WDA & MIA 4. Turnkey EU Launch solutions: Packaging, Labelling, Distribution & Testing (Via Alliances) 6. Support for IMPD and Market Authorisation (MA) submissions MIAS operates in a hub and spoke model with a core group of MIAS employees being able to rely on a group of international associates to flex up/down capacity depending on clients requirements. About MIAS Pharma Ltd MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. Primary customers are small to medium Pharma / Bio-Pharma companies that look to enter the EU market but do not have required Manufacturing and Importation licence or the Quality/Regulator expertise to comply with complex EU / UK regulations. In recent times MIAS also supports CMOs, CROs, Packaging companies and Testing companies QP solutions to take the burden off internal resources. MIAS Pharma delivers two main solutions: 1. A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace) 2. Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market. MIAS Pharma also provides: 1. European & UK Qualified Person (QP & QA) services 2. QP Audit programs 3. QMS Design: WDA & MIA 4. Turnkey EU Launch solutions: Packaging, Labelling, Distribution & Testing (Via Alliances) 6. Support for IMPD and Market Authorisation (MA) submissions MIAS operates in a hub and spoke model with a core group of MIAS employees being able to rely on a group of international associates to flex up/down capacity depending on clients requirements. MIAS Pharma Supports Companies to carry out both Clinical Studies and Commercial Product launches in Europe and the UK. We hold licences known as MIA's which allow us to import and QP release your products. As part of our service offering we can support you with: - EU / UK set-up - We can support your IMPD / MA submissions - Via our partner companies we can support Market Access, commercialisation and Distribution - QP Release - Product testing and retains - Audit Programs - WDA and RP Services