eRA 2019 Conference and EXTEDO User Group Meetings

Register now for the unique learning and networking opportunity for Regulatory Affairs and Drug Safety professionals from around the globe.

22-23 May 2019, Munich, Germany

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eSUBmanager Simplifies The Reviewing Of eCTD And Other Electronic Standards

eSUBmanager is a modern SaaS solution, that is designed to facilitate the review of electronic submissions throughout your company and partner network.

eSUBmanager Free Trial

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 Consulting Services

No matter if you need support with converting old NeeS submissions to eCTD, general publishing support, or an expert for stremlining your business processes - EXTEDO's experts can help you.

OUR SERVICES OFFERINGS

Regulatory Software Solutions for a Global Community

EXTEDO enables more than 35 regulatory authorities and 850 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 a top 30 pharma company

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

Technical validation: A bottleneck in the drug registration process?

In this article, we go through some of the general technical validation requirements and how to better understand them.

Brexit-related Topics Relevant to Medicinal Product Registration

There are currently many ongoing activities and discussions relating to Brexit and its potential implications across many different sectors.

中国药品监督管理局（CDA）开始要求使用eCTD标准

中国药品监督管理局（CDA）宣布，eCTD将成为中国境内电子提交材料的强制性标准。尚未开始为新的监管要求做准备的生命科学组织收到建议，其需要迅速采取行动，以满足即将来临的最后期限。

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Latest Events

Informa / K-Nect365 eRegulatory Summit 2019

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

SAAPI Conference 2019

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

eRA 2019 Electronic Regulatory Affairs Conference and EXTEDO User Group Meeting

Save the date for EXTEDO's eRA 2019 conference!

DIA 2019 Global Annual Meeting

Meet EXTEDO at booth no. 2041!

BioAsia 2019 Taiwan

The first global biotech event held in Taiwan

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