Resources by type

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eCTDmanager in the Cloud Product Flyer

Download the flyer to learn more about EXTEDO's eCTD management software solution in the cloud.

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RImanager Product Flyer

Dowload the product flyer to learn more about EXTEDO's regulatory planning and tracking software.

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EXTEDOsuite Flyer

Download the flyer and learn more about the EXTEDOsuite.

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MPDmanager Product Flyer

Download the flyer to learn more about EXTEDO's ISO IDMP compliant registration management solution.

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EURS Product Flyer

Download the product flyer to learn more about EXTEDO's eCTD validation and reviewing solution.

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SafetyEasy MD Product Flyer

Download the product flyer to learn more about EXTEDO's medical device safety solution offering.

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SafetyEasy PV Product Flyer

Download the flyer to learn more about EXTEDO's E2B R2 & R3 pharmacovigilance management software.

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EURSvalidator Product Flyer

Download the product flyer and learn more about EXTEDO's NeeS and eCTD validator.

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eSUBmanager Product Flyer

Download the product flyer to learn more about EXTEDO's eCTD viewing and reviewing solution.

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eCTDtemplates Product Flyer

Download the eCTDtemplates Product Information to learn more about EXTEDO's eCTD Word Templates.

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eCTDmanager Product Flyer

Download the product flyer to learn more about EXTEDO's submission management solution.

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RImanager Case Study: Optimizing Regulatory Data by Implementing RImanager at Kern Pharma

The implementation of RImanager allowed Kern Pharma to have a single data source for all regulatory products and processes. This has greatly improved...

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PcVmanager Case Study Ludwig Institute for Cancer Research

Ludwig turned to EXTEDO for help automating their pharmacovigilance processes and with the help of PcVmanager, developed an adverse event ...

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PcVmanager Case Study Pharmathen

Pharmathen is a private pharmaceutical company focused on the development and marketing of pharmaceuticals. The company is responsible for the...

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PcVmanager Case Study Genericon

Genericon develops, manufactures and sells medicines containing proven, non-patented active substances of the latest generics.

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MPDmanager Case Study: Comprehensive medicinal product data management

Our client is an international company with 500+ employees that focuses on the sale of pharmaceuticals in over 100 countries.

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DOCmanager Case Study Top 25 Pharma Organization

Our client, a global company with Global Regulatory Affairs functions distributed across several sites worldwide, was faced with the challenge of...

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eCTDmanger Case Study PHF

PHF SA, Pharmaceutical Group Holding FIS, is a Swiss-based pharmaceutical company that develops, manages and implements projects within the fields...

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eCTDmanger Case Study Fresenius Kabi

Fresenius Kabi, a subsidiary of Fresenius SE, is the European market leader in infusion therapy and clinical nutrition.

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eCTDmanger Case Study Hepalink

Chinese-based bio-pharmaceutical company Hepalink Pharmaceutical was looking for a solution to ensure compliance with global regulatory submission...

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eCTDmanger Case Study Pierre Fabre

Pierre Fabre Laboratory is the second largest independent French pharmaceutical laboratory.

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eCTDmanger Case Study MEDA Pharma

MEDA Pharma GmbH & Co. KG is the German subsidiary of the leading Swedish pharmaceutical company MEDA.

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eCTDmanger Case Study Optum

OptumInsight provides global regulatory consulting services for the pharmaceutical, biotechnology and medical device industries.

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eCTDmanger Case Study BlueReg

BlueReg Pharma Consulting is an independent Regulatory Affairs and Pharmacovigilance service company based in France.

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eCTDmanger Case Study Qilu

Qilu is an Active Pharmaceutical Ingredient (API) manufacturer based in China. They are widely known for the development and production of active...

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eCTDmanger Case Study Fuzhou Fuxing Pharmaceutical Co., Ltd (fxPharm)

With  the  growing  use  of  eCTD  around  the  world  and  its  imminent  introduction in China, fxPharm turned to EXTEDO to provide regulatory...

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Whitepaper: Understanding the standards, challenges and opportunities introduced by the new E2B R3 standard

This whitepaper outlines the most pressing challenges faced by organizations in order to comply with E2B(R3) in a timely and cost-effective manner....

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Whitepaper: eCTD 4.0: Objectives, benefits & impact on life science organizations

In this white paper we will explore the evolution of the eCTD format, what is changing in the next major version, and what are the objectives and...

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Whitepaper: An Introduction to eCTD

eCTD is the industry standard used by many countries around the world for the transfer of drug applications.

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Whitepaper: Regulatory Information Management Systems - A Catalyst for Technological Innovation within the Life Sciences Industry

In this whitepaper we explore the benefits of Regulatory Information Management Systems as a catalyst for technological and process innovation.

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Whitepaper: Is ISO IDMP a cost or incredible opportunity for your business?

What is the purpose of IDMP? IDMP is the new ISO standard for the unique identification of medicinal products. It enables consistent documentation,...

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EXTEDO eCTDmanager Customer Interview: Glenn Robertson, Puma Biotechnology

Glenn Robertson talks about his experience with EXTEDO's eCTD software solution eCTDmanager and how it helped saving time and money.

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EXTEDO eCTDmanager Customer Interview: Sandra Hartbach, Drehm Pharma

Sandra Hartbach, Head of Regulatory Affairs and IT at the Austrian CRO Drehm Pharma talks about 10 years experience with EXTEDO's software solution...

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EXTEDO PcVmanager Customer Interview: Stefan Zohmann, Drehm Pharma

Stefan Zohmann explains why EXTEDO's PcVmanager covers Drehm Pharma's requirements on adverse event case management and talks about his experiences...

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EXTEDO EURS Customer Interview: Estelle Taute, Medicines Control Council South Africa

Estelle Taute talks about the implementation of eCTD at South Africa's regulatory authority MCC (Medicines Control Council) and how EXTEDO's ...

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EXTEDO eCTDmanager, PcVmanager and MPDmanager Customer Interview: Remco Munnik, ASPHALION

Remco Munnik, Regulatory Information Director at the Spanish CRO ASPHALION, talks about many years experience with EXTEDO's software solutions...

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EXTEDO eCTDmanager Customer Interview: Ted Hanebach, Mapi (now ICON)

Ted Hanebach at the Canadia CRO Mapi (now ICON) talks about many years experience with EXTEDO's software solution eCTDmanager and all the services, ...

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