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eCTD & NeeS

Electronic submissions

Your objective : submit a dossier which is fully compliant with Health Authorities requirements. According to the chosen procedure and local idiosyncrasy, options will be eCTD, NeeS, or paper format. Involved in submission procedures for many years, A.R.C. Pharma consultants have all skills and tools to guarantee a full compliance of your dossier, regardless of the format.

A.R.C. Pharma has acquired a specific software solution* for MA dossiers, managing both eCTD and NeeS. This dedicated application is compliant with ICH standards for all three regions (EU, USA, Japan). It is continuously updated to follow-up regulatory evolutions and is compatible with the software used by European agencies.

A.R.C. Pharma consultants have the expertise to manage all steps of the dossier processing : create, assembly, validate, publish and submit a complete (or partial) eCTD or NeeS dossier, or edit a paper version if necessary.

A secured hosting of your data can be ensured upon request, enabling their update and facilitating electronic submission of variations, throughout the lifecycle of your MAs.

*ENNOV

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