Tips For A Successful eCTD Conversion
Feb13

Tips For A Successful eCTD Conversion

With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion.

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Is Your Company Prepared for the FDA eCTD Mandate?
Feb06

Is Your Company Prepared for the FDA eCTD Mandate?

Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?  

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FDARA Marketing Status Reports Due
Jan31

FDARA Marketing Status Reports Due

Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.

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Health Canada Revises Rules for eCTD Submissions
Dec08

Health Canada Revises Rules for eCTD Submissions

Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions.

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Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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Document Reuse, Lifecycle and Metadata Overhauled in eCTD v4.0
Jul07

Document Reuse, Lifecycle and Metadata Overhauled in eCTD v4.0

The focal points of eCTD v4.0 like document reuse, enhanced lifecycle control and more liberal use of metadata, and the ability to alter that metadata if errors are made, are countermeasures to the limitations of eCTD v3.2.2. Overall, these enhancements represent common sense solutions that give regulatory professionals a more efficient way of doing business.

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