Irish firm Mias Pharma helping non-EU firms enter single market

With the prospect of a hard Brexit growing more likely by the day, Mias Pharma's offering to the market could hardly have been timelier. The company offers pharmaceutical firms from outside Europe access to the single market and European Economic Area (EEA) by providing them with the required manufacturing and importation authorisations.

"The timing is working out perfectly," says CEO Ann McGee who founded the company in June of last year. "We didn't establish the business with Brexit in mind, but it is generating great opportunities for us. In the past, companies targeting the EU market tended to look to the UK first as a stepping stone because of its large domestic market. They are now looking at Ireland instead and anticipating having two Brexit products live by the end of next year."

Marketing a pharmaceutical product in the European Union is a difficult and complex undertaking, McGee explains. “When a company wants to come into the EU with a product such as paracetamol they have to set up a company in the EU and obtain a licence for the product. Making a medicine is like making a cake. A recipe containing active ingredients, excipients and other ingredients is used. All these ingredients might come from different manufacturers around the world and each has to comply with best manufacturing practice as laid down by the EU.”

Highly regulated

All of that has to be audited and the process doesn’t stop there. “All of these materials come together in the manufacture of the finished product. The manufacturing process is highly regulated. We provide the auditing service and the oversight of the manufacturing process. We confirm that the manufacturer will product the product to the right standard every time.”

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Packaging and distribution are also highly regulated and requires auditing and oversight. “The documentation that is included with a product has to meet certain standards and transportation has to be secure to prevent interception, counterfeiting and so on. A whole series of different documents are required to confirm that a batch of pharmaceuticals is in compliance with the various regulations. That’s what we do. It’s highly technical and complex.”

Market response has been very encouraging. "We spent our first nine months getting our licence from the Health Products Research Authority, " says McGee. "We were out introducing ourselves to potential clients at the same time. We are targeting companies from outside the EU who want to sell into Europe. We started with California and already have three active projects in place. We will have five or six clients by the end of the year. We are in a low-volume, high-value business and we only need three to four new clients a year to grow the business."

The company is also set up to scale rapidly should the need arise. “We operate a hub and spoke model with a small team at headquarters backed up by a network of professional consultant associates who are available to work on projects as required.”