Regulatory Affairs


Newport is responsible for the regulatory function of its Irish operation in addition to providing support to the Group Regulatory Functions in the markets of CEE.

At Newport we promote product safety and quality through ensuring we operate and comply to GMP and GDP.
Our Activities include:

Drug Substance:

  • Preparation of Product Dossier
  • DMF Preparation
  • License Management

Drug Product:

  • Obtaining and Maintaining Marketing Authorisations
  • Representing the company’s practices, processes and products to regulatory agencies