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Requirements of eCTD Publishing Jobs in Canada

ECTD publishing jobs in Canada are not as many as in USA although there are many qualified personnel around. Most of these jobs are found in Ontario and Quebec.  Activities related to eCTD publishing in Canada are  usually taken up by regulatory affairs personnel than designated eCTD publishers.
Education and Training for eCTD Publishing
Generally a Bachelor’s […]

By |April 25th, 2016|ECTD|Comments Off on Requirements of eCTD Publishing Jobs in Canada

ECTD validation rules regulate Bookmarks and Hyperlinks in Regulatory Submissions

Regulatory agencies employ different eCTD validation rules to to ensure that all dossiers meet the same regulatory standards. In this article I will discuss some eCTD validation rules used by Health Canada in relation to PDF documents , hyperlinks and bookmarks.
Validation Software and eCTD Validation Rules
There are several types of  eCTD Validation software. They may […]

By |April 15th, 2016|ECTD|Comments Off on ECTD validation rules regulate Bookmarks and Hyperlinks in Regulatory Submissions

Proper organization of eCTD files and folders for Submissions to Health Canada

The sequence folder contain all the ectd information.  When you submit an application for market authorization Regulatory agencies such as Health Canada apply certain validation rules to determine compliance with the eCTD guidelines. Your submission will not be accepted unless it complies with the guidelines. Submitting an eCTD dossier is team work. Several people will […]

By |April 7th, 2016|ECTD|Comments Off on Proper organization of eCTD files and folders for Submissions to Health Canada

How to apply for a product licence to sell a NHP in Canada

A product licence is required for the  sale of  Natural Health Products(NHPs) in Canada unless you are a retailer. You are  not allowed to sell a natural Health product without a product licence even if you claim its doctor formulated as I have seen lately.

If the licence is cancelled or suspended, you are not allowed […]

By |April 2nd, 2016|natural health products|Comments Off on How to apply for a product licence to sell a NHP in Canada