Regulatory Affairs
Niche’s regulatory affairs department is based in Clonmel, Co. Tipperary, Ireland. It comprises of a Registration manager, a post Licencing manager, Regulatory affairs officers and a Regulatory office administrator.
The regulatory affairs department is responsible for the registration of new products across Europe and for maintaining marketing authorisations following approval. A key function of the regulatory staff is advising management and customers as to the various registration options for each product and identifying the most appropriate reference member state if a mutual recognition procedure is planned. In addition the department provides support to customers who purchase Niche dossiers with a view to registering these products themselves. The regulatory staff has extensive experience of using both the national route and Mutual Recognition Procedure to register products.
Maintaining current marketing authorisations is also an essential element of the work of the regulatory department usually by means of variations and at the appropriate time, renewal of the licences.
The regulatory department works closely with both the development and commercial departments and is therefore involved in the complete lifecycle of each new product.
Each team member is assigned his or her own product/project with responsibility for ensuring that the product is accurately registered and maintained.
Within the department the emphasis is on continuous training and the need to keep fully up to date with current EU Guidelines, legislation and relevant publications.
Niche dossiers have been successfully submitted and are currently under assessment in the following territories: The E.U., Eastern Europe, South Africa, Australia and New Zealand.
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