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Who are we?
Ivowen Limited was set up in 2002 by Majella Ryan and Kay O'Shea to cater to the growing needs of generic pharmaceutical companies in the fields of Regulatory Affairs consultancy and Project Management. In July 2004 Ivowen Limited recruited a new regulatory affairs consultant, Áine Cunningham and in June 2006 Marie-Louise Nolan joined the team. Between them, they have over forty 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, Kay, Áine and Marie-Louise have all worked for large, multi-national generic pharmaceutical companies, which deal with both EU and non-EU marketing areas.
Kay O'Shea
 Kay has managed a Regulatory Affairs department, consisting of a team of ten regulatory staff & four analysts. During this time she was responsible for five complex MRPs involving multiple customers & all EU territories, as well as national submissions within the EU & in South Africa, NZ, Central and Eastern Europe, & parts of Asia.
Kay was also in charge of Regulatory Strategy for all applications, which included SmPC harmonisation and meeting with Competent Authorities where necessary. She was involved in licensing products developed by external companies, including the review of dossiers. Biostudy management experience included sourcing Contract Research Organisations, study design, management of the studies from GCP aspects & review of final reports.
In addition to the above, Kay has Project Management, licence maintenance and development & analytical experience, including the management of an aerosol development laboratory, from previous employments.
Majella Ryan
Majella
has been Project Manager for 15 development projects, all
involving development by external companies, and implemented
Project Management systems within the company.
She has furthermore, been responsible for the development, dossier compilation and submission of complex abridged applications for generic products, including a suspension and a sustained release product. These products were progressed through the EU Mutual Recognition Procedure. This work included full SmPC comparisons, regulatory submission strategies and full data reviews.
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.
Both
Majella and Kay have prepared and run training courses for
numerous generic pharmaceutical companies in Regulatory Affairs,
Drug Development, Sales and Marketing Opportunities, 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.
Furthermore she has re-formatted dossiers into the new Common
Technical Document (CTD) format, prepared SmPC comparisons
to establish regulatory strategies for EU wide generic submissions,
and prepared and submitted dossiers using the MRP system.
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. For further information
on herbal medicines please click
here
Marie-Louise Nolan
Marie-Louise, also one of our regulatory affairs consultants, has a PhD in Biochemistry from UCD and has varied experience in the generic pharmaceutical and medical device industries. Her expertise includes the preparation and submission of abridged applications, variations and renewals, for both human and veterinary medicinal products, and dealing with EU and US regulatory systems.
Marie-Louise is also a former pharmaceutical assessor with the Irish Medicines Board where she was responsible for the evaluation of administrative, quality and safety data submitted in support of applications for variations to or renewal of marketing authorisations for human medicinal products in accordance with national, mutual recognition and centralised procedures.
Furthermore she has re-formatted dossiers into the new Common Technical Document (CTD) format, prepared SmPC comparisons to establish regulatory strategies for EU wide generic submissions, and prepared and submitted dossiers using the MRP system.
In addition to the above Marie-Louise has formulation development and stability testing experience on a range of new formulations (metered dose and breath operated devices) in an FDA-approved laboratory.
Marie-Louise has also lectured in biology, microbiology and biochemistry
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.
For further information on any service available at Ivowen Limited, please contact us.
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