Marketing Authorisation Submissions

CPS can help you with all submission requirements: we can coordinate the complete submission, assist with ad hoc associated tasks, and we can also act as the MA holder on your behalf.

National registrations – For generic applications when only one country is sought to market, CPS can assist with all filing requirements. We can also assist where a mandatory local person is required for MA approval.

Whether you are filing via Mutual Recognition or Decentralised Procedures (MRP & DCP) – We can help. CPS works closely with our clients to recommend the most efficient route to market. From recommending the most suitable RMS for DCP submissions through to country fee calculation, providing local consultants where mandatory, and coordinating national phases.

Centralised Procedures (CP) – CPS is poised to assist with CP’s as well but due to their complex and individual nature, please contact us to discuss your specific project needs.