Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2018) there are almost 300 orphan drugs commercially available and more than 400 orphan designated drugs at clinical trial phase. As the sector […]
Our medical device client is a very well regarded award winning company with facilities around the world. We have been retained to assist them in recruiting a QA/RA Supervisor for two of their Irish facilities. One in Munster and one in Connaught. This role is an ideal role for an individual seeking to make that […]
Acorn Regulatory has been retained by a dynamic Irish pharmaceutical company to recruit a Director of Regulatory Affairs for their expanding facility. The successful candidate will have the opportunity to utilise their expertise in an entrepreneurial setting and to contribute to the growth of the company. The company has a portfolio of successful products that […]
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations and the critical issues that you need to be aware of when completing a variation.
Acorn Regulatory staff took part in a number of the Enterprise Ireland & IDA Trade Mission events in Dublin and Sligo recently. The purpose of the trade missions was to facilitate networking opportunities between Enterprise Ireland clients (of which Acorn Regulatory is one) and IDA Ireland multinational companies.