CMC321 Consulting
Your Module 3, Our concern
CMC321 Consulting
Your Module 3, Our concern
For an easy Module 3
Module 3 authoring
A new MA dossier ?
An update ?
A pharmaceutical variation ?
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We author for you the Module 3 and all other documents necessary for the submission.
Development support
You want to optimize the filling of a strategic variation ?
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We help you designing the necessary studies for the submission of an adequate dossier.
audit of
module 3
You have a business development project ?
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We perform the due diligence of the
Module 3.
post submission
support
You need help following the submission of a new Module 3,
a pharmaceutical variation ?
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We support you in elaborating a strategy for adequate answers to HA questions
Throughout the lifecycle of your medicinal product, we are by your side to maintain a compliant CMC dossier.
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At development stage, we help you setting the studies necessary to elaborate
an optimized Module 3 from a regulatory standpoint.
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We author for you a high quality and easy to maintain Module 3.
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We provide you with a regulatory support for all your industrial changes.
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You have a wide project of Modules 3 baselining, we help you setting up and coordinating the project.