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

eCTD Related Guidelines for US FDA and EU

With the FDA eCTD mandate for INDs and DMFs upon us, now all original applications and lifecycle submissions for human drugs and biologics must be...

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.

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Latest Events

DIA 2018 Annual Meeting

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Informa/KNect 365 Crop Innovations and Regulations 2018

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EXTEDO EURS Experts Meeting / Training

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...

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