Nees

NeeS has been used as a transitional format towards the mandatory use of eCTD and is now only accepted in some specific
cases.
A NeeS differs from an eCTD in that it does not contain an XML backbone or the quantity of MD5 checksum values as defined
by the ICH - it is in essence, a collection of electronic files organised in folders.

S P Solutions support Nees Format for following Regulatory authority

• Europe

• Gulf Corporation Council (GCC)

• Australia

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We fulfills the following NeeS validation criteria

• EU NeeS – Validation Criteria 4.3

• GCC NeeS – Validation Criteria 1.2 and 1.4

• AU NeeS – Validation criteria 1.0