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Scientific Area

eCTD: Updating the Dossier Submission Format

We are Azierta, experts in updating the file submission format.

European regulations have established a process to update the format for sending medication files to the Competent Authorities in order to manage the life cycle of the established traceability drug.

Azierta make it easier for our clients to adapt to the regulatory changes ICH eCTD through the following services:

consolidation of the dossiers

Necessary support to carry out the consolidation of the dossiers, creating the necessary consolidation sequence for each client.

eCTD sequences and maintenance

Generation of the eCTD sequences and maintenance of the trees of the life cycles of the medicines in our archive.

Development of eCTD sequences from a NeeS

Development of eCTD sequences from a NeeS sequence or from the separate documents for clients who do not have these softwares (simplification of the process and cost savings).

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

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