In the last months, the eCTD format became mandatory for CEP submissions to the EDQM and for DMFs for Health Canada.

We look forward to meeting you at our virtual booth!

Register now free of charge!

Register now free of charge.

We invite you to join EXTEDO's first Virtual Regulatory Agency User Group Meeting for EURS and EURSnext customers.

As a direct result of the outbreak of the coronavirus disease (COVID-19), EXTEDO has decided to replace this event by virtual meetings.

We invite you to join EXTEDO's first Virtual Regulatory Agency Innovation Day, which will take place on 07 May 2020.

As a direct result of the outbreak of the coronavirus disease (COVID-19), EXTEDO has decided to replace this event by virtual meetings.

We invite you to join EXTEDO's first Virtual Pharmacovigilance User Group Meeting for PcVmanager and SafetyEasy PV customers.

We invite you to join EXTEDO's first Virtual Innovation Day, which will take place on 05 May 2020.

As a direct result of the outbreak of the coronavirus disease (COVID-19), EXTEDO has decided to replace this event by virtual meetings.

We invite you to join EXTEDO's first Virtual eRegulatory User Group Meeting for eCTDmanager and eSUBmanager customers.

As a direct result of the outbreak of the coronavirus disease (COVID-19), EXTEDO has decided to replace this event by virtual meetings.

We invite you to join EXTEDO's first Virtual Innovation Day, which will take place on 29 April 2020.

In recent times, Health Canada published several new regulations related to eCTD and SPL, which will affect your submissions to the Canadian…

As a direct result of the outbreak of the coronavirus disease (COVID-19), EXTEDO has decided to replace this event by virtual meetings.

Pharmacovigilance audits are a crucial component of any pharmaceutical company’s Quality Management System - some are already done remotely.

Register now free of charge!

Update 10 March: The workshop will take place.

Meet us at DIA RSIDM (Regulatory Submissions, Information, and Document Management Forum) 2020

Register now free of charge!

Один из наиболее актуальных и наболевших вопросов каждой фармацевтической компании – переход на новые стандарты ЕАЭС и выбор эффективных моделей…

Our consultants will give you an overview of our service offerings and explain how we can support you and your organization.

With the goal of making medicine safe for people all over the world, there are few issues more important than drug safety. And while predicting the…

EXTEDO invites you to its complimentary webinar "Effortless Collaboration - Reduce the Complexity of Viewing and Reviewing with eSUBmanager".

The aim of the North Africa Regulatory Conference is to bring together key stakeholders and to discuss ways of improving access to medicines and…

The 13th DIA Middle East Regulatory Conference (MERC), shaped in partnership with the EFPIA Middle East Regulatory Network (MERN), is built on the…

The effective management of validated and compliant electronic submissions is complex. To ensure effortless compliance you need submission…

Meet EXTEDO at booth no. 1

EXTEDO and VtR invite you to their joint Regulatory Best Practices Workshop on 25 September 2019 in Taipei, Taiwan. During the workshop, we will talk…

Join the Epista Knowledge & Network Day 2019 to turn Life Science obstacles into opportunities. Professionals in quality, regulatory, IT, production,…

La Empresa de Tecnologías de la Información (ETI) del Grupo de las Industrias Biotecnológica y Farmacéutica de Cuba (BIOCUBAFARMA), convoca a la…

Meet the EXTEDO team at booth #303

EXTEDO invites you to its complimentary webinar "US FDA Grouped Submissions - Agency Requirements and Best Practices for Submission Management".

Meet our local partner Bio & Gene in the exhibition area!

The first global biotech event held in Taiwan

Meet EXTEDO at booth no. 2041!

The event will have two tracks that you can choose from, with different topics covering EU and US Regulatory, Quality by Design, the new Medical…

Save the date for EXTEDO's eRA 2019 conference!

The South African Association of Pharmacists in Industry (SAAPI) is hosting its Annual Conference on 16 and 17 May 2019 at the CSIR International…

Get 25% discount with the EXTEDO code and visit us at our booth!

The event has been canceled.

Under the patronage of Dr. Mohammed Al-Rubaie, the general director of Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC),…

Meet the EXTEDO team at booth no. 200!

A chance to learn, engage, and grow as a healthcare professional.

Meet the EXTEDO team at booth no. J1306 !

EXTEDO customers will receive 25% off the registration rate by using a special invitation promo code.

EXTEDO invites you to its Complimentary Webinar:
Challenges of complying with NeeS and eCTD Validation Requirements globally

It is our great pleasure to invite you to the 18th Annual Meeting of the International Society of Pharmacovigilance (ISoP 2018), “Pharmacovigilance…

 EXTEDO and Generis invite you to their Complimentary Webinar

"EXTEDO eCTDmanager and Generis CARA Integration: See how one of the top three German…

Meet the EXTEDO colleagues on site!

Meet us at the EXTEDO booth!

Meet the EXTEDO Team at booth no. 607!

Meet EXTEDO and our partner ASPHALION in the exhibition area!

Visit EXTEDO at our booth and learn the latest news on IDMP in Christian Kravogel's presentation slot.

Meet the EXTEDO colleagues on site!

Register now for our upcoming EURS Experts Meeting on 11-12 September and the training courses in the morning before! This event is for delegates from…

Get 25% discount with the EXTEDO VIP code

Visit EXTEDO and our partner Bio & Gene at booth no. 1!

From January 2019, all submissions for pharmaceutical products marketed for humans within the EU have to be submitted in eCTD format or they will be…

Meet the EXTEDO team at booth 908!

This seminar will provide a structured introduction to all important aspects of FDA Regulatory Affairs, but will also cover current Hot Topics as well…

Register now for our upcoming PcVmanager User Group Meeting on 07 June and/or the training courses on the day before!

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

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。

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,…

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

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

Looking for a seamless process and move your regulated content to the cloud using a best-of-breed approach?
Over the last 3 years, EXTEDO and Veeva…

Save 25% with the EXTEDO promotion code and meet the EXTEDO experts in the exhibition area!

EXTEDO and NeoTrident would like to invite you to their workshop and eCTDmanager training courses, taking place in Shanghai from 23rd April – 27th…

EXTEDO and NeoTrident would like to invite you to their free eCTD workshop taking place in Shanghai on 23rd April 2018!

Meet EXTEDO in the exhibition hall at booth no. 65!

EXTEDO and ASPHALION invite you to their Complimentary Webinar "Regulatory Information Management: Challenges and Opportunities".

Register now for our upcoming North American User Group Meeting on 22 March and/or the training courses on the day before!

从2018  年 5 月起，所有提交给美国 FDA 的新药主文件（DMFs）以及与现有DMF相关的任何其他提交材料，必须以 eCTD 格式提交。创腾科技携手 EXTEDO 邀请您参加2018 年 3 月 9…

From May 2018, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be…

Meet EXTEDO in the exhibition area at booth no. 200!

This event is organized by the British Herbal Medicines Association (BHMA) and EXTEDO experts will give an overview about the eCTD standard there.

Meet the EXTEDO Team in the exhibition area!

EXTEDO invites you to its complimentary webinar about the new EU ADR Reporting Rules

Meet the EXTEDO team there!

25% discount for EXTEDO customers. Meet the EXTEDO Team in the exhibition area! 

如何让最安全、有效和高质量的药品以最经济高效的方式得到批准和上市是药品监管部门、制药企业的共同心愿。从2008年起，FDA开始鼓励以eCTD(electronic Common Technical…

In combination with the Werum User Group Meeting in Lüneburg, Germany - register now free of charge!

Meet the EXTEDO team at booth no. 5!

中国食药监机构已经宣布，将在2018年开始强制实施eCTD格式的电子递交。eCTD最初是由ICH提出，目前是世界上许多国家作为药物注册申报的标准。为了能够在中国药检机构实施eCTD格式时做好充分地准备和竞争力，现在2017年9月28日下午2点，足不出户，网络线上会议将为带来一次免费的eCTD的介绍之…

Register soon to get your seat!

Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in…

Meet the EXTEDO team at our exhibition table!

Over two days you will learn the key aspects of RIM and the new IDMP standard such as training and user compliance, outsourcing and data/content…

Visit us at booth no. 413!

Meet EXTEDO at booth no. 2!

This workshop will provide an overview of the history of eCTD, i.e. why we have the standard, the eCTD structure and life cycle management.…

With eCTD submissions becoming mandatory for all submissions within the Greek market, is your organization ready?

EXTEDO´s Partner ASPHALION organizes a complimentary webinar titled "Data extraction from SmPCs into structured data for ISO IDMP compliance". They…

Register for our eCTD workshop in Taiwan!

BioTaiwan Exhibition has been the Asia’s leading integrated bio marketplace for years. Meet us there!

(This event will be in German) Jetzt müssen für alle europäischen Zulassungsverfahren die Dossiers im eCTD vorlegen - in diesem Seminar lernen Sie…

Visit us at booth 612!

On February 24th, the EMA published the latest version of the EU eSubmission roadmap. Besides the adaption of eCTD 4.0/ RPS timelines, it includes…

We are excited to announce the 4th edition of our FDA OPEN SEMINAR!

(This event will be in German) Diesen eSubmission- und Datenbankverpflichtungen müssen Sie 2017 nachkommen...

Join us at eRA 2017, the Electronic Regulatory Affairs Conference and EXTEDO User Group Meeting on 10-11 May 2017 in Majorca, Spain

This seminar will address peculiarities in developing and submitting an eCTD within the ICH region as well as in worldwide eSubmisssion requirements.

EXTEDO is sponsoring this event, meet us there and save 25% by registering through our link or code.

Meet us at booth no. E8!

From May 5, 2017, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be…

Meet us at booth no. 400!

From May 5, 2017, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be…

Meet the EXTEDO team in the exhibition area!

Meet the EXTEDO team in the exhibition area!

In this session, you will learn how to get started with IDMP in your organization. We will discuss the details of what should be included within a…

EXTEDO invites you to its Complimentary Webinar "New FDA Study Validation Criteria - A Practical Guide for Regulatory Professionals". 
On October 3,…

It's a common problem - there is never enough space to fit everything you want onto medicinal packages. With the pressures of compliance increasing,…

In this session, you will get detailed insights into the information that must be delivered to EMA in the first phase of the IDMP roll-out. We will…

EXTEDO and its partner NeoTrident are delighted to invite you to a day dedicated to networking, information sharing and best practices discussions…

This hands-on training held by EXTEDO's eCTD expert Ralf-Peter Berg, enables participants to understand regional differences and global submission…

With the imminent release of the IDMP standard many organizations are wondering how their business will be impacted and what they need to do to remain…

Workshop presented by MOPI and EXTEDO - Introduction and best practices about electronic in eCTD format in Kuala Lumpur, Malaysia

We kindly invite you to its upcoming RIMS workshop in Midrand, South Africa on 17th October 2016.

EXTEDO invites you to its Complimentary Webinar "Reporting of Serious and Non-Serious Cases within EXTEDO´s Drug Safety Management Solution".

We kindly invite our partners to join this year's EXTEDO Partner Day.

We kindly invite our agency customers to join this year's EURS Experts Meeting in Amsterdam, Netherlands. In addition to the 2-day meeting, we are…

See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators and EXTEDO. This is where it all comes…

Meet the EXTEDO team in Singapore and see “Success of the eCTD standard worldwide and rollout to Asia”, presented by EXTEDO's CEO Martin Schmid.

EXTEDO invites you to its Complimentary Webinar "Tracking of Cases and Tasks with EXTEDO´s Drug Safety Management Solution".
During the webinar, Andrea…

NTA, CTD, eCTD - Ihre Schritte bis 1.1.2017

EXTEDO invites you to its Complimentary Webinar "Cloud Content Management and Publishing - Delivering Value and Efficiency".
Join this webinar to see…

This event provides an unique opportunity for EXTEDO users to meet and exchange information and experiences among each other and with the EXTEDO…

This event provides an unique opportunity for EXTEDO users to meet and exchange information and experiences among each other and with the EXTEDO…

EXTEDO and ASPHALION invite you to their webinar "Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database".

During the webinar…

EXTEDO invites you to its webinar "The Updated Version of the ISO IDMP Standard".

On the 6th of May, ISO TC 215 health informatics will decide on the…

During the last couple of months, the IDMP expert team at ISO has intensively worked on the revision of the IDMP standard and the finalization of the…

The EMA has announced that the new eCTD Module 1 version 3.0 standard will become mandatory on 1st October 2016. To help you prepare and understand…

Meet the EXTEDO team in Hamburg at booth no. K10!

Book the EXTEDO eCTD Masterclass now and meet the EXTEDO Team in Dubai!

Meet us at the EXTEDO booth no. 300!

EXTEDO and Veeva partner to provide an innovative method for moving regulatory content to the cloud.