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.
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.
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
