Norgine Development

The vision of Norgine Development is

Developing ethical, quality products for patients, with scientific and commercial value, to deliver sustainable growth for Norgine.

through

Flexible efficient teams with a sense of urgency and accountability.

We are responsible for developing Norgine’s product pipeline and further developing our current products through clinical trials and other activities to improve the presentation or formulation of our products. These activities are managed through our cross functional matrix project teams led by our Therapy Area Development Teams who manage all our interventional clinical trials. Therapy Area Teams consist of Clinical Development, Regulatory Development and Project Management staff who are aligned to projects to work closely together to lead the development of our pipeline.

Medical and Regulatory Affairs are responsible for ensuring our product information is kept up to date and then submitting and maintaining our product licences and clinical trial applications. They also ensure that important updates are communicated to regulatory authorities. Additionally we manage Global Pharmacovigilance activities for all our marketed and pipeline products and work closely with partners to ensure that all our safety data are up to date.

Our Pharmaceutical Development team based in our newly built Norgine Development Centre in Hengoed, research the best methods of producing our pipeline products for use in clinical trials before transitioning the scale up to full manufacturing production. They provide essential information that allows us to successfully run our studies and ensure that high quality products are produced.

The Preclinical Development team are responsible for the earliest projects in our pipeline through their work with partner organizations to develop innovative products before they reach clinical trials. In addition they provide expertise and resource for the preclinical requirements for full development projects.

The Intellectual Property team develop and maintain patent protection for our products to ensure that Norgine innovations are protected. They also ensure that we can commercialise our products successfully without impacting third party patents, and defend Norgine products against action by those who may infringe our own activities.

All of these activities are underpinned by Development Quality which is part of our Global Quality function to ensure that the appropriate quality is present in all our activities, and ensuring compliance with external regulations and our own internal standards.

Our Medical and Regulatory Affairs departments have links into many of the countries in which Norgine operates. Staff in these teams play a vital role in managing governance for our commercial activities as well as working closely with their Commercial colleagues to deliver patient focused solutions for the optimal use of our products. In addition the Medical Writing Team are a key part of the Medical and Regulatory Affairs department by ensuring that critical documents for both marketed and pipeline products are expertly written to the correct quality standards.