We are Azierta, experts in the preparation and maintenance of the medication registration dossier.
What are we specialized in?
- Review of dossiers in sales processes: viability assessment of the documentation prior to the acquisition and estimation of the necessary costs and time to align with the current legislation.
- Review and consolidation of old dossiers with any modifications that have occurred over the years, and which are required before starting the European registration process.
- Review and consolidation of dossiers with factory documentation
Our Regulatory team also conducts audits in registration departments with a view not only to consolidating all the dossiers, but also to help to organise the structure of the department’s global file.