[title type=”special-h4-left”]Technical Pre-Submission Consultation[/title]
[content_box type=”with-header” title=”For guidance and assistance for the filing process of eCTD”]
Sponsors filing a regulatory activity in eCTD format for the first time are recommended to request a technical pre-submission consultation with Health Canada. This consultation is held to clarify needs, responsibilities, and expectations, as well as to provide Health Canada the opportunity to offer assistance and guidance for the filing process in eCTD format. This consultation does not necessarily need to take place at the same time as the regulatory pre-submission meeting. To request a technical pre-submission consultation, contact Office of Submissions and Intellectual Property (OSIP).
Atinza will assist clients to submit necessary information to Health Canada prior to this meeting and can also accompany clients or act on behalf of clients to meet and discuss with Health Canada.
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[title type=”special-h4-left”] Pre-submission Meetings[/title]
[content_box type=”with-header” title=”Another meeting with Health Canada prior to submission”]
Sponsors may wish to deliver a brief presentation to the appropriate Directorate within Health Canada prior to filing a New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS), Clinical Trial Application (CTA), combination product classification request or request for Priority Review or NOC/c status.
Atinza will support clients to submit request for the meeting to appropriate Regulatory Affairs Division (BGTD) or Regulatory Project Manager (TPD). We will ensure the request contains all contents as per required by Health Canada and ensure that meetings are well-organized, efficient, productive, and properly documented.
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