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Purchase Card ManualPurchasing and Contracting Department Updated January 2021TABLE OF CONTENTS OVERVIEW ........................................................................................................................................

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How to fill out ich-m-4-s-common-technical-document-registration

01

Fill out the Applicant Details section with all the required information such as name, address, and contact details.

02

Provide detailed information about the product being registered in the Product Details section.

03

Complete the CTD Module 1 section with the necessary administrative information.

04

Ensure all relevant supporting documents are included with the application.

05

Review the completed application form for accuracy and completeness before submission.

Who needs ich-m-4-s-common-technical-document-registration?

01

Pharmaceutical companies seeking to register a new medicinal product

02

Manufacturers of medical devices

03

Biotechnology companies developing new therapies

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What is ich-m-4-s-common-technical-document-registration?

ICH M4S Common Technical Document Registration is a standardized format for submitting technical documentation to regulatory authorities for approval of pharmaceutical products.

Who is required to file ich-m-4-s-common-technical-document-registration?

Manufacturers and sponsors of pharmaceutical products are required to file ICH M4S Common Technical Document Registration.

How to fill out ich-m-4-s-common-technical-document-registration?

ICH M4S Common Technical Document Registration must be filled out according to the guidelines provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

What is the purpose of ich-m-4-s-common-technical-document-registration?

The purpose of ICH M4S Common Technical Document Registration is to ensure that all necessary information about a pharmaceutical product is provided to regulatory authorities for review and approval.

What information must be reported on ich-m-4-s-common-technical-document-registration?

ICH M4S Common Technical Document Registration requires detailed information about the pharmaceutical product, including its composition, manufacturing process, and clinical data.

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