Norgine Develoment

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.  Our Clinical Development and Medical teams manage Phase I-III and Phase IV clinical trials respectively, and Medical are also responsible for ensuring our product information is kept up to date. Our Regulatory Affairs team submit and maintain our product licences and clinical trial applications and 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 Technical 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 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.

Our Product Development / Project Management team oversee all aspects of our pipeline through our project teams, to ensure optimal use of resources for project success, based upon the delivery of significant patient benefit.

All of these activities are underpinned by Development Quality which is part of our Global Quality function to ensure that top 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.

 

Global Quality

Global Quality covers all functional quality groups within Norgine and specifically oversees Development Quality, Corporate Quality and Manufacturing and Supply Quality.  Norgine has a commitment to embedding quality in all its activities and this is overseen by the Norgine Quality Council (NQC).  The NQC is chaired by the Chief Operating Officer and has senior management membership from Manufacturing and Supply, Commercial, Development, Finance and Global Quality.

One of the groups in Global Quality is the Corporate Quality group who own and operate the Norgine Quality Management System and associated QA activities.  In addition they provide oversight and independence to the quality system and perform system audits on various regulated functions.  Other functional and site Quality groups own and operate parts of the QMS and QA within their individual scopes of responsibility

 

Development Quality

All of Norgine’s Development activities are underpinned by the Development Quality group. Working closely with other quality staff in both Corporate Quality and other Norgine functions, to ensure a consistent approach, the Development Quality team work with Development line functions and project teams to agree and monitor Norgine standards that will meet or exceed external regulatory requirements.

 

Our Development Quality team oversee our regulated processes through management of Standard Operating Procedures and their training, as well as using audits and inspections as a check of compliance and as a learning tool. Building quality thinking and actions into our culture is our aim, by remembering that patients are at the core of our activities and it is they that benefit from the quality in every aspect of our work.

 

Quality Management System

 

Norgine is dedicated to ensuring that quality is at the heart of everything we do from product development, manufacturing and supply through to promotion and sales. The goal of Norgine is to achieve a high level of customer satisfaction at all times. Commitment to the implementation of supporting managerial and business operational systems is essential to realising that goal.

 

Management are committed to the continuous improvement of the QMS by establishing and reviewing quality objectives for all areas of Norgine. This is to ensure that Norgine operates effectively and efficiently and meets the needs of customers.