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Who are we?
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 IMB. Audrey has over 8 years experience in the Health Authority side's handling of applications, procedures and systems.
Majella, Áine and Susan have all worked for large, multi-national generic pharmaceutical companies, which deal with both EU and non-EU marketing areas.
Majella Ryan
 Majella has been involved in Regulatory Affairs since 1996.
Majella has run numerous parallel DCPs into all EU MSs, as well as advising clients on the development and regulatory strategy for their products. She has extensive experience with writing Quality Overall Summaries. She has also been involved in User Testing preparation and review for many generic products.
She has furthermore been responsible for the development, dossier compilation and submission of complex abridged applications for generic products, including a suspension and modified release products. These products were progressed through the EU Mutual Recognition Procedure and Decentralised Procedure. This work included full SmPC comparisons, regulatory submission strategies and full data reviews.
She has project managed more than 20 development projects, all involving development by external companies, and implemented Project Management systems within these companies.
With the Paediatric Regulation in force since January 2009, she has prepared and advised on Paediatric Investigation Plan submissions for new and combination products.
She has also prepared and reviewed toxicokinetic and risk assessments for submission to competent authorities and completed analytical method development and validation for a GLP contract research organisation, for drugs and other non-pharmaceutical compounds.
Majella has prepared and run training courses for numerous generic pharmaceutical companies in Regulatory Affairs, Drug Development, Sales and Marketing Opportunities, Biostudies, etc. For further information on training please go to our
Training
page.
Áine Cunningham
Áine has been responsible for the running of a Regulatory Affairs department in the Irish subsidiary of a large multinational generics company. Her key duties included the preparation and submission of standard abridged applications, variations and renewals. Áine was also responsible for the introduction of a regulatory compliance system (preparation of Standard Operating Procedures and establishing a system for regulatory compliance audits).
Áine has been involved in the development of a pharmacovigilance system which included the preparation of Product Safety Update Reports (PSUR) and maintenance of the Adverse Drug Reactions (ADR) database.
Áine has also prepared dossiers for both veterinary and human applications and has managed many applications through the national, MRP and DCP routes including post authorisation submissions, e.g. variations, renewals and transfer applications. Áine has experience with many of the EU members states in preparing electronic submissions in line with individual MS requirements (e.g. NeeS). She has also sourced and compiled harmonised SmPC, PILs and labelling and has co-ordinated readability testing with user-testing facilities.
Furthermore she has established regulatory compliance systems and performed compliance audits in various companies (both originator and generic).
In addition to the above Áine has experience in the preparation and registration of biocidal products throughout Europe, Asia, North and South America.
Áine is the responsible contact person at Ivowen Ltd. for traditional herbal medicinal products and for the area of regulatory compliance. For further information on herbal medicines and regulatory compliance please click
here
Susan Geoghegan
Susan has been involved with the pharmaceutical industry for over 10 years and her experience ranges from Intellectual Property to Regulatory Affairs.
Susan has over 5 years experience working in private Patent Law firms in Dublin and London where she specialised in biotechnology related inventions. Susan's work supported the role of the firm's Patent Attorneys and involved detailed reviews of prior art documents with a view to establishing patentability.
Susan then moved to a Regulatory Affairs role within a large Irish generic pharmaceutical company whose primary product range includes liquids, creams/ointments and powders. In this position she was responsible for the preparation and filing of abridged applications, variations, renewals and PSURs.
Susan has successfully managed human medicinal product applications through the DCP and MRP systems and the subsequent post-authorisation filings, e.g. variations, renewals and PSURs, required to maintain the various marketing authorisations. She has experience working with many of the regulatory agencies/Health Authorities throughout Europe as well as those in New Zealand (MedSafe) and Australia (TGA).
Susan was responsible for a large project to co-ordinate PIL-user testing on over 100 products and the subsequent national filings and dealing with Health Authority questions.
In recent years, Susan was responsible for managing the regulatory activities of over 120 Marketing Authorisations and was responsible for establishing appropriate regulatory systems for managing this portfolio. During this time Susan successfully co-ordinated the in-licensing of several products ensuring launch on date of patent expiry where applicable.
Audrey Butler 
Audrey has over 8 years experience working for one of the most well-respected Health Authorities in the EU – the Irish Medicines Board. She has varied experience in the human medicines and veterinary areas of the IMB. Her key duties included being the primary contact for applicants and Health Authority assessors alike from across the EU, including the EMEA. On a daily basis, she was responsible for the management of applications, including new MR & DCP applications, both as RMS & CMS, new Centralised applications, variations, renewals and transfers for human and veterinary medicinal products. Audrey was also a leading project team member in the implementation of the IMB's tracking and project management system, which has resulted in the IMB's assessment times being drastically reduced in the last few years.
In her capacity at the Irish Medicines Board, Audrey was responsible for the evaluation of administrative data submitted in support of applications for MRPs, DCPs, Centralised Procedures and Scientific Advice procedures for human medicinal products in accordance with EU legislation. Audrey was Case Manager for all applications involved in the above mentioned procedures, and thus was responsible for the co-ordination of applications from point of allocation to licensing of Marketing Authorisations.
Since joning Ivowen Limited, Audrey has been responsible for
- Researching, locating and booking suitable DCP/MRP slots for clients.
- Preparation and submission of Transfer Applications to various Health Authorities on behalf of our clients. This includes price applicaitons where appropriate.
- Preparation and submission of Variation Applications to various Health Authorities on behalf of our clients.
Provides full administration support in preparing and submitting of DCP applications, both paper and electronic.
Fiona Downey 
Fiona has worked in a Regulatory Affairs role within a large Irish generic pharmaceutical company whose primary product range includes liquids, creams/ointments and powders. In this position she was responsible for the preparation and filing of variations, renewals and national, MRP and DCP applications.
Fiona has also worked as a Deputy QPPV, in this position she was responsible for the preparation and submission of PSURs and expedited reports. Fiona also maintained the pharmacovigilance system within the company, including the maintenance of the DDPS, SOPs, safety data exchange agreements with distributors and co-marketers and preforming literature searches and signal detection.
Currently Fiona is the QPPV for Ivowen Limited and is registered with EudraVigilance. In her capacity as QPPV Fiona can:
- Prepare company-specific DDPS
- Prepare company-specific PV SOPs
- Audit internal and external PV providers
- Set up of new Marketing Authorisation Holders on PV Database
- Electronic reporting via EudraVigilance
- Prepare PSURs
- Provide full weekly literature searches via PubMed Medline
For further information on any service available at Ivowen Limited, please contact us.
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