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eCTD submissions

ELECTRONIC COMMON TECHNICAL DOCUMENT

The electronic Common Technical Document (eCTD) has become the standard for numerous regulatory agencies across the world.

Handling electronic regulatory submission requires proper planning and an understanding of regulatory requirements. 

With AlphaGreen Resources Inc., book of dead online kostenlosyou won’t need to worry about any of the technical requirements; all you have to do is provide the appropriate information.

  • Why choose AlphaGreen Resources Inc. for eCTD Publishing Services.

    • We help our clients understand the standards and guidelines setup by the FDA and Health Canada.
    • We assist for obtain a pre-assigned application number
    • We prepare the documents compatible for electronic submissions
    • We maintain proper structure for various modules in submission.
    • We prepare XML backbone for total submission including regional xml, index xml, study tag files, SPL (structured product labeling)
    • We compile, validate, publish and submit your regulatory applications to the FDA and Health Canada via WebTrader Electronic Submissions Gateway.

    AlphaGreen Resources Inc., provides expertise in all eCTD requirements and supports you until the FDA accepts your application.

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Phone: +1 519 996-3735
Email: info@alphagreenresources.com

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