What Are The Benefits?
Companies seeking to avail of our MIA can utilise it without having to substantially invest in the costly and thorough process of obtaining their own MIA licence. This involves implementing a full quality management system (QMS). Partnering with Acorn Regulatory, companies can benefit in three ways:- Timeline reduction: Developing a QMS and starting the MIA application process can take up to 12 months. Collaborating with Acorn Regulatory will accelerate the lead-time. It is also worth noting that Ireland is the only English-speaking country in the European Union.
- Financial savings: It is financially more cost-effective to contract Acorn Regulatory to provide the required quality services instead of setting up an office and hiring a team of full-time employees in the EU.
- Experience: Acorn Regulatory has a cross-functional team that supports clients every step of the way. Acorn Regulatory employees have extensive industry experience in Quality, Regulatory Affairs, Operations and Supply Chain and have a proven track record of delivering results for clients.
Options for QP Release for Clients:
- Your company can get listed on the Acorn Regulatory MIA Licence so that our experienced staff can release your batches to the EU market on your behalf. This saves time, work and expense and will not require setting up your own legal entity in Europe.
- You can also set up a private limited company in Ireland. This requires, at a minimum, a General Manager and a QP. A Quality Management System (QMS) must be put in place for the QP to perform batch release. When the QMS is operational you will need to apply for the MIA with the Health Products Regulatory Authority (HPRA) of Ireland. This can take up to 12 months and a good working relationship with the HPRA is essential.
