The EMA has issued a statement of intent regarding the future integration of CESP and the EMA eSubmission Gateway to create a Common European Single Submission Portal or ‘CESSP’ (Link). This single portal shall be built using the current CESP portal and the first version is expected to be available by Q1 2018.
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
- Brexit support services