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BH International. The Global Pharma Consultants BH International expertise is Dossier preparation for registration of products globally. Also, we pr

28/07/2023
26/07/2023

What are the advantages of eCTD format (electronic submission) of Dossier presentation?

In simple terms, the following are the advantages both from the dossier presenter & regulator point of views

1) Searching, viewing & reading relevant information is much easier than paper formats.

2) The documents can be easily reused for multiple submissions.

3) The documents are comparitively compact in size and space saving is done to a large extent.

4) Electronic gateway can be used for automatic submissions & errors can be reduced

5) Many people can view the different parts of the same document at the same time.

6) Reviewing & researching the document is easier due to indexing & search tool option.

7) The format allows you to manage the dossier lifecycle & thus have complete history of submissions at hand.

8) Considerable cost reduction as compared to paper submissions

What are your thoughts? Any additions?


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05/07/2023

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