Our Research and Development department plan and co-ordinate the development of novel and differentiated generic products from formulation through to clinical trials. This is completed to GLP (Good Laboratory Practice) standard. This department also provides support to our Regulatory Affairs team who are then responsible for steering the new product application through to registration. There is no single ‘harmonised’ approach taken by all the world’s regulatory agencies. Our Regulatory Affairs department are therefore highly skilled in understanding the nuances of regulatory requirements and negotiating with agencies in order to progress variations to existing products as well as gaining approvals for new products.
Our Technical Validations Team are responsible for providing documented evidence that all our processes, procedures, facilities and equipment perform compliantly and consistently. Each year this team complete in excess of 600 projects. Their work not only supports routine manufacture of existing products but also ensures the optimisation of processes etc. for new products.
