T-TOP Clinical Research Co., Ltd. is a Taiwanese CRO that provides various services, including…

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

EXTEDO Company Video - Effortless Compliance with Regulatory Information Management Solutions

We have created an infographic containing tips & tricks on how to stay ahead and ensure patient…

Highlighting the technical aspects across all 4 initiatives.

Our experts talk about how IDMP compliance will become an important topic in the veterinary sector…

Manage clinical trials, track quality processes and organize regulatory submissions.

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

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,…

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

Our team of validation experts have prepared an infographic with tips & tricks for software…

Our publishing services team has prepared an infographic with tips & tricks for building EU…

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

EXTEDOpulse is a complete end-to-end Regulatory Information Management System (RIMS) covering…

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,…

How to prepare submission-ready documents, how to submit publications the easy way and what to check…

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

Asphalion and EXTEDO provide you a series of infographics on the regulatory requirements in…

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…