Regulatory Affairs Services:
(MAAs) New Marketing Authorisation Applications »
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eCTD »
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Post Marketing »
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Pharmacovigilance »
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PIPs and PUMAs »
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Veterinary Medicines »
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CEP »
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Other Services »
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Welcome to Ivowen Limited
Ivowen Limited was set up in 2002 to cater to the growing needs of generic pharmaceutical companies in the fields of Regulatory Affairs consultancy and Project Management. Áine Cunningham, a specialist regulatory affairs consultant joined the company in 2004 and Susan Geoghegan joined in 2011. Between them, they have over thirty years experience in generic pharmaceuticals, ranging from formulation and analytical development to regulatory affairs and project management.
In January 2008, Audrey Butler joined us from the Irish Medicines Board. Audrey has over 8 years experience in the Health Authority side's handling of applications, procedures and systems.
Our QPPV, Fiona Downey joined us in 2011, and is active in the new legislation changeover and transition.
Our latest team members, Orla Finneran and Sarah Robertson, joined in June 2012. Their technical backgrounds make them ideal additions to our expanding team.
Majella, Áine, Susan and Fiona have all worked for large, multi-national generic pharmaceutical companies, which deal with both EU and non-EU marketing areas.
What our clients say!
We have consistently used Majella and Ivowen for regulatory filing support and advise on regulatory issues. In addition to being a good and honest person, I have found Majella to be extremely knowledgeable, capable, trustworthy and above all giving the right advice and guidance.
USV Limited Testimonial »
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I have worked with Ivowen over a number of years now, and have always found them extremely easy to work with. They are flexible and knowledgeable in their approach and project are delivered on time and within budget. Majella and her team will always “go the extra mile” to look into complicated issues and try to find new ways of approaching problems
Global Top Ten Pharmaceutical Company Testimonial »
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BrePco Biopharma Ltd., has used the services of Ivowen from the beginning of our project in November 2009. They were critical to us during our Paediatric Investigation Plan application and our subsequent meetings with the European Medicines Agency, resulting in an approved PIP within the tight regulatory timelines.
BrePco Biopharma Ltd Testimonial »
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The phrase “one‐stop‐shop” has become a bit of a cliché; but that is exactly what Ivowen offer. To aid projects through the early proof of concept stage to final international approval.
CF Pharma Limited Full Testimonial »
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AFT Pharma has worked with Ivowen for a number of years to assist us with our EU regulatory strategy, which otherwise is extremely complex for non EU residents. We have found them to provide a friendly, knowledgeable and cost effective service to help us navigate this complexity.
AFT Pharmaceuticals Ltd Testimonial »
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Ivowen Limited is:
Committed to providing expert advice on Regulatory Affairs and Project Management to the generic pharmaceutical industry, enquire here!