New EAEU Submission Standard Will Become Mandatory

Two years ago, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions. From December 2020 all initial marketing authorization applications must be submitted in the new format. eCTDmanager already supports the new EAEU submission format. If you are planning submissions in EAEU countries, let us know. We also provide EAEU Publishing Services.

eCTDmanager Publishing Services

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"After the implementation of DOCmanager and due to the parent-child-concept, expenditure of time for an international dossier rollout has dropped from 6 months to 1-2 months"

Director, Regulatory Informatics and Submission Management at a top 30 pharma company

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"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd

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Director Business Development, Technical Operations and International Business at Genericon

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"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

Quality Assurance & Regulatory Affairs Manager at PHF SA

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The EXTEDOsuite for Regulatory Information Management and eCTD

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The EMA announces that E2B(R3) will become mandatory from 30 June 2022

In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory as of 30 June 2022.

3 Vital Cloud Migration Considerations

This blog has been formulated to help guide you on your transition to the cloud and to assist you in finding the ideal cloud provider for your…

Benefits of the Cloud for Life Science Companies

In this blog post, we talk about the benefits of the cloud and how they apply to organizations within the life sciences industry.

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