Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA,…

EXTEDO’s MPDmanager simplifies the process of maintaining IDMP and XEVMPD data, delivering a single…

Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA,…

Easily validate medicinal and veterinary electronic submissions with the validator that is used by…

EXTEDOpulse makes your life easier by connecting your systems in a way that makes sense for maximum…

EXTEDO’s MPDmanager simplifies the process of maintaining IDMP and XEVMPD data, delivering a single…

A complete eCTD and NeeS validation and reviewing solution used by over 35 authorities worldwide,…

Classify, create, review, submit and maintain pharmacovigilance, medical device vigilance,…

Classify, create, review, submit and maintain pharmacovigilance, medical device vigilance,…

Easily validate medicinal and veterinary electronic submissions with the validator that is used by…

Reduce the complexity of viewing and reviewing archived and in-progress electronic submissions.

Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA,…

Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA,…

Our client, a global company with Global Regulatory Affairs functions distributed across several…

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

Chinese-based bio-pharmaceutical company Hepalink Pharmaceutical was looking for a solution to…

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

OptumInsight provides global regulatory consulting services for the pharmaceutical, biotechnology…

BlueReg Pharma Consulting is an independent Regulatory Affairs and Pharmacovigilance service…

Qilu is an Active Pharmaceutical Ingredient (API) manufacturer based in China. They are widely…

This whitepaper outlines the most pressing challenges faced by organizations in order to comply…

In this white paper we will explore the evolution of the eCTD format, what is changing in the next…

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

In this whitepaper we explore the benefits of Regulatory Information Management Systems as a…

Merck KGaA, one of the top 3 pharmaceutical companies in Germany, has previously selected their new…

What is the purpose of IDMP? IDMP is the new ISO standard for the unique identification of…

Glenn Robertson talks about his experience with EXTEDO's eCTD software solution eCTDmanager and how…

Sandra Hartbach, Head of Regulatory Affairs and IT at the Austrian CRO Drehm Pharma talks about 10…

Estelle Taute talks about the implementation of eCTD at South Africa's regulatory authority MCC…

Remco Munnik, Regulatory Information Director at the Spanish CRO ASPHALION, talks about many years…

Ted Hanebach at the Canadia CRO Mapi (now ICON) talks about many years experience with EXTEDO's…