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This document outlines the process for proponents and consultants to request a pre-submission consultation with the Toronto and Region Conservation Authority (TRCA) prior to submitting applications related to various infrastructure projects. It includes sections for applicant and project information, as well as guidelines on meeting types and required submissions.
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How to fill out request for pre-submission consultation

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How to fill out request for pre-submission consultation

01
Gather necessary documents and information relevant to your submission.
02
Fill out the request form by providing your contact details.
03
Clearly describe the purpose of the consultation and any specific questions you have.
04
Provide details on the product or service you are seeking consultation for.
05
Review the form for accuracy and completeness.
06
Submit the request via the designated channel (online portal, email, etc.).
07
Wait for confirmation of your request and follow up if necessary.

Who needs request for pre-submission consultation?

01
Anyone planning to submit a regulatory application for a new product or service.
02
Companies seeking guidance on regulatory requirements and processes.
03
Individuals who require clarification on specific issues related to their submission.
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A request for pre-submission consultation is a formal communication submitted to regulatory authorities to discuss proposed submissions and clarify requirements before the actual submission of a product application.
Typically, pharmaceutical and biotechnology companies seeking marketing approval for new products or significant changes to existing products are required to file a request for pre-submission consultation.
To fill out a request for pre-submission consultation, applicants need to complete a standardized form provided by the regulatory authority, detailing their product information, intended use, and any specific questions or topics they wish to discuss.
The purpose of a request for pre-submission consultation is to receive feedback from regulatory authorities on the proposed submission, identify potential issues early, and facilitate a smoother review process.
Information that must be reported includes the applicant's contact details, a description of the product, its intended use, proposed clinical studies, and specific questions or concerns regarding the submission.
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