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MIAS Pharma

MIAS Pharma Ltd specializes in supporting pharmaceutical and biopharmaceutical companies in the efficient and compliant importation and manufacture of products in the EU/EEA. Our regulatory framework facilitates the import of medicinal products and the certification of batches, while our Qualified Person (QP) services ensure the regulatory-compliant release of investigational and commercial products onto the market.

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About Us

MIAS Pharma supports pharmaceutical and biopharmaceutical companies in obtaining compliant access to the EU, EEA, and UK markets through manufacturing and import authorizations (MIA), wholesale distribution authorizations (WDA), services related to Qualified Persons (QP) and Responsible Persons (RP), as well as support for Marketing Authorization Holders (MAHs) and expertise in GMP/GDP compliance.

As part of the Normec Group, MIAS Pharma combines local regulatory expertise with the strength of an international network of life sciences specialists. Together, we offer integrated solutions in the areas of quality, regulatory affairs, and laboratory services, helping organizations meet legal requirements while reducing operational complexity throughout the entire product lifecycle. MIAS Pharma Ltd specializes in helping pharmaceutical and biopharmaceutical companies import and manufacture products in the EU/EEA efficiently and in compliance with regulations. Our licensing framework facilitates the import of medicinal products and the certification of batches, while our Qualified Person (QP) services ensure the compliant release of investigational and commercial products onto the market.

Contact us

  • MIAS Pharma | Irish Office
    Suite 1, Stafford House, Strand Road, Portmarnock, D13 WC83, Dublin, Ireland
    +353 (01) 846 3605
    info@miaspharma.com
  • MIAS Pharma | UK Office
    Vision Park, Chivers Way, Histon, Cambridge, Cambridgeshire, CB24 9AD, United Kingdom
    +44 1954 604099
    info@miaspharma.com

Services

Explore our services and discover how we can support you. With a wide range of solutions, we help you address a variety of challenges, tailored to your organization.

QP services

Clinical QP services

GMP/GDP Storage

Personnel and training for QP, QA & RP

Regulatory affairs

GxP compliance and auditing

Medical Team Performing Surgical Operation in Bright Modern Operating Room

Quality Management System (QMS)

Program and Project Management

News

Normec is leading the way. Stay up to date.

17 Dec 2025

A day in the life of a QP at MIAS Pharma

A Qualified Person (QP) plays a pivotal role in the pharmaceutical industry, ensuring that every batch of medicine certified meets the strictest quality and regulatory standards. The role is legally mandated in the EU and UK under Good Manufacturing Practice (GMP) regulations and is essential for safeguarding public health. Here’s a glimpse into activities for a routine day for a QP.

07 Apr 2026

MIAS Pharma will be attending the BIO International Convention in San Diego, USA

MIAS Pharma is excited to attend the BIO International convention in San Diego, California, from June 22nd – 25th 2026. Visit us at booth #4052, we’ll be happy to connect.

27 Feb 2026

MIAS Pharma: End to End MAH services for Virtual and Rare Disease Companies

For small and virtual companies, especially those developing rare disease medicines, the requirements of acting as a Marketing Authorisation Holder (MAH) in the EU can feel overwhelming. EU legislation places the MAH at the centre of responsibility for the quality, safety and efficacy of the product throughout its lifecycle, regardless of how many activities are outsourced. MIAS Pharma is designed to be your one integrated partner in Europe: an established presence with the expertise, infrastructure and network to assume day‑to‑day MAH obligations on your behalf while you focus on science, patients and portfolio strategy.

01 Apr 2026

Let’s Meet at SNMMI Annual meeting 2026 LA

MIAS Pharma is excited to attend the SNMMI annual meeting in Los Angeles, California, from May 30th – June 2nd 2026. Visit us at booth #1363, we’ll be happy to connect.

20 Mar 2026

Labelling & Packaging: A Core MAH Responsibility

Marketing Authorisation Holders (MAHs) carry primary responsibility for the accuracy, control, and lifecycle management of labelling and packaging across all markets where a product is placed on the EU/EEA market. This obligation extends beyond artwork creation to encompass regulatory approval, change control, supply chain implementation, and post‑market vigilance for labelling‑related quality defects and recalls.

13 Mar 2026

Getting ready for product launch with serialisation

As your medicinal product moves from the clinical space into commercial launch territory, one crucial question looms large:

06 Mar 2026

MAHs: Are Your GMP–GVP Interfaces Aligned?

Calling all Marketing Authorisation Holders (MAHs) are you set up for success? Have you confirmed whether your five‑year renewal is required? Is this critical information visible and accessible to your QPs and QPPVs?

We are part of the Normec Group.

Normec is a leading organization in the TICC sector (Testing, Inspection, Certification, Compliance). Our scope of work ranges from (drinking) water quality, air quality, and soil quality to fire safety, food safety, management systems, fair labor practices, good working conditions, and social compliance. Every day, we work to create a safe, healthy, and reliable work and living environment—for this generation and future generations.