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MIAS Pharma

MIAS Pharma

Dublin, Ireland· Est.
miaspharma.com
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Private Company

Total funding raised: $15M

Overview

Founded in 2015 and headquartered in Dublin, MIAS Pharma is a specialized service provider in the pharmaceutical sector, focusing on regulatory and quality compliance for the EU and UK markets. Its core business model revolves around providing Qualified Person (QP) services, Marketing Authorisation Holder (MAH) services, and GxP consulting, enabling clients to import, certify, and commercialize medicinal products without establishing their own legal entity in Europe. The company is privately held, revenue-generating, and serves a broad range of therapies from small molecules to advanced therapies, positioning itself as an essential outsourcing partner for global drug developers.

Drug DeliverySmall Molecules

Technology Platform

Integrated regulatory and quality service platform built on held Manufacturing/Importation Authorisations (MIA), a network of certified Qualified Persons (QPs), and end-to-end systems for Marketing Authorisation Holder (MAH) services, batch release, and GxP compliance.

Funding History

2
Total raised:$15M
Series A$12M
Seed$3M

Opportunities

The growing trend of outsourcing non-core regulatory functions by global biopharma, especially virtual and US/Asia-based companies, presents a major opportunity.
The complexity of EU/UK market access and the expansion of advanced therapies (ATMPs, biologics) that require specialized regulatory handling create sustained demand for MIAS's integrated service model.

Risk Factors

Key risks include regulatory/compliance failure, which is existential for a service based on quality assurance; dependency on a limited pool of certified Qualified Person (QP) talent; and vulnerability to changes in EU/UK pharmaceutical legislation.
Client concentration and competition from larger CROs and consultancies also pose threats.

Competitive Landscape

MIAS competes with other regulatory consulting firms, some CROs, and larger CDMOs that offer similar EU market access services. Its differentiation lies in its specialized, Ireland-based focus, integrated 'one-stop-shop' approach from MAH to batch release, and broad expertise across diverse drug modalities including advanced therapies.

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