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.

OUR AGENCY CUSTOMERS

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

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...

eSubmission Roadmap: The Decline of NeeS & the Roadmap to eCTD

Within the EU dossiers for medicinal products marketed for humans could be submitted in two electronic formats: NeeS and eCTD. The end of 2018 will...

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Latest Events

DIA Europe (30th Annual EuroMeeting) 2018

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

Free eCTD Workshop in Shanghai: Are you ready for eCTD?

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

Are you ready for eCTD-based DMFs? You only have two more months to be compliant!

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

Informa eRegulatory Summit 2018: Global eCTD Management / Regulatory Information Management and IDMP Compliance

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

10th DIA China Annual Meeting

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

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