Regulatory Affairs

The regulatory group covers the whole range of products and activities, from products in development through marketed products and in-licensing opportunities.  They provide regulatory support from development to submission and beyond, including line extensions and new indications. 

Regulatory affairs also play a part in the company’s business development activity, when products with potential for in-licensing are evaluated and where expert understanding of the drug development process is required. The Regulatory team plays a key role in developing regulatory strategy and leading the regulatory activity on project teams and also works closely with manufacturing and supply to ensure that all elements of CMC come together.