Regulatory Affairs

NEOX's regulatory affairs section is based on the knowledge of local experts with experience and understanding in regulatory processes, national guidelines and procedures with different types of registration, such as national, centralised, decentralised or mutual recognition procedure.

We also provide an all-inclusive assessment of the dossier, as well as any relevant documentation to ensure a smooth registration process. On top of this, we can also offer scientific advice of any issues relating to the registration documentation.

Key responsibilities

The key responsibilities of our regulatory affairs managers include:

• Coordinating and preparing documents for registration submissions
• Managing all communication with regulatory authority
• Dossier compilation in eCTD format
• Review of dossier quality in eCTD format
• National, centralised, decentralised and mutual revognition procedures
• Variations and renewals