Management of electronic submissions for pharmaceutical industry
P2 eCTD is the pharmaceutical industry version of our publishing solution, P2. In addition of paper and electronic publishing features.P2 eCTD also offers a full management of eCTD format submission sequences, in addition of paper-based and electronic publishing features.
Manage the lifecycle of electronic submissions of AMM folders in the eCTD format.
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In combination with D2, P2eCTD represents an overall, fully ,configurable solution covering the life cycle of documents and submissions with equal flexibility.
Within the same environment, P2 eCTD allows document drafting, modification and validation to continue whilst initiating a new submission or finalizing a sequence.
As the change to eCTD should not mean that data repositories are multiplied or the traceability, integrity or management of the document database compromised. C6 offers with P2 eCTD, the management of the submission cycle in a single system.
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Use of P2eCTD it is :
- Submissions building.
- Submissions life cycles control.
- Incorporation of all eCTD standards deployed by ICH and the regional regulation authorities (US, EU, CA).
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Get more:
Rapidly view eCTD files stored in Docbase Documentum with our streamlined eCTD viewer:
e2.
