Description

CMC321 Consulting CMC321 Consulting - Expertise in Pharmaceutical Regulatory Affairs. Writing of Module 3 - When preparing a new MA dossier, an update, a pharmaceutical variation, we write for you the Module 3 and all other documents that are necessary for the submission. Post-submission - You need help following the submission of a new Module 3, a pharmaceutical variation ? We support you in elaborating a strategy for adequate answers to MoH questions. Development support - You want to optimize the filling of a strategic variation ? We help you setting the studies that are necessary for the submission of an adequate dossier. Audit of Module 3 - You have a project of business development ? We perform the due diligence of the Module 3.

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