EXTEDO eCTDmanager and PcVmanager User Group Meetings

Join us at our upcoming eCTDmanager and PcVmanager Training and User Group Meetings on 05-07 June 2018 in Munich, Germany! Learn about the latest product and regulatory roadmaps, and get tips and tricks which will make your work easier!

eCTD EVENT DETAILS PcV EVENT DETAILS

Innovative eCTD, RIMS, PV and IDMP Software Solutions and Services

EXTEDO is the only vendor that provides software solutions and services covering the entire regulatory landscape. The EXTEDOsuite combines innovation with compliance, and quality with usability.

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Regulatory Software Solutions for a Global Community

EXTEDO enables more than 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance. Our clients range from small CROs to large multi-national pharmaceutical organizations.

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Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

The EXTEDOsuite supports the critical relationship between the pharmaceutical industry and regulatory authorities, ensuring that your life sciences business operates a compliant and efficient product registration and maintenance process.

PRODUCT REGISTRATION & IDMP SOFTWARE

SUBMISSION MANAGEMENT & eCTD SOFTWARE

PHARMACOVIGILANCE AND DRUG SAFETY SOFTWARE

REGULATORY PLANNING AND TRACKING SOFTWARE

"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 Merck Serono

Learn more about EXTEDO DOCmanager

"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

Learn more about EXTEDO eCTDmanager

"EXTEDO is a great example of a company that really understands the requirements of the market"

Director Business Development, Technical Operations and International Business at Genericon

Learn more about EXTEDO

"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

Learn more about our training offerings

The EXTEDOsuite for Regulatory Information Management and eCTD

EXTEDO‘s focus is on optimizing clients‘ eRegulatory business processes. The EXTEDOsuite is unique in that it covers the complete regulatory landscape.

SOLUTIONS FOR LARGE COMPANIES

SOLUTIONS FOR SMALL COMPANIES

SOLUTIONS FOR REGULATORY AGENCIES

Submission Platforms in EU and Further Changes

In this article, we will talk about EMA eSubmission gateway, CESP (Common European Submission Platform) and the future of both platforms; CESSP...

PDF requirements for US FDA eCTD submissions

In below sections I will discuss some portable document format (PDF) specifications that you should also consider while publishing your submissions.

Submission of eCTD submissions to US FDA using the electronic gateway

We are upon uncertain times within the Regulatory world. The FDA has already started moving toward making eCTD mandatory for all submissions by May of...

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Latest Events

Complimentary Webinar: EXTEDO eCTDtemplates - Simplifying the Authoring Process of eCTD Dossiers

We would like to invite you to our Complimentary Webinar "EXTEDO eCTDtemplates - Simplifying the Authoring Process of eCTD Dossiers".

10th DIA China Annual Meeting

Visit EXTEDO and NeoTrident at our joint booth no. D11!

Introduction to Electronic Submissions in eCTD Format and Best Practice for US FDA Submissions

隨著全球醫藥品通用技術文件電子化(eCTD)及電子送件(e-Submission)的日益盛行，世界各國已大多陸續採用以eCTD的方式來接受NDA, ANDA, IND, BLA,...

2018 US FDA eCTD Electronic Submissions and Trends

今年5月起，美國 FDA 開始強制執行 eCTD 送件。有效管理經過驗證和合規的提交送件是一個複雜的過程。基於標準化提交送件格式構建，查看，驗證和發布送件的需求帶來了一系列挑戰。此外，在多個地區提交送件還要求所有提交產品必須符合 ICH 和地區規範，這會使整個過程進一步複雜化。

EXTEDO eCTDmanager European User Group Meeting / Training

Register now for our upcoming European eCTDmanager User Group Meeting on 06 June and/or the training courses on the day before!

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