Use your resources in a structured and effective way

Make your business processes more efficient and safer

Stay compliant with the latest international regulations

At EXTEDO, we understand the challenges faced by small and midsize life science companies and CROs. Limited resources and escalating regulatory requirements can make the approval process seem like an insurmountable hurdle - that's where we come in. 

 As the only vendor capable of covering the entire regulatory landscape, we offer configurable off-the-shelf solutions that address your unique business and regulatory needs. With a rich history of successful partnerships with SMBs and CROs worldwide, we bring a wealth of experience to the table. Whether you're struggling with understaffed regulatory affairs teams, increased pressure on costs, or the demands of proper documentation and record-keeping, EXTEDO has the answers you seek. Embark with us on a journey towards streamlined operations, improved efficiency, and compliance excellence. 

Contact us today to discover how we can transform your regulatory landscape. Together, we'll ensure your products reach national health authorities smoothly and securely.

Are you struggling with regulatory challenges?

With ever-increasing regulatory requirements and data volumes, the approval-process is becoming more and more challenging.

  • I'm overwhelmed by navigating through the complex regulatory landscape
  • Limited resources restrict our ability to handle regulatory tasks effectively
  • My Regulatory Affairs Team is understaffed, making it challenging to keep up with regulatory tasks and submissions
  • I'm under a lot of pressure due to higher costs, and I need to find ways to be more efficient
  • Collaborating with regulators and addressing their requests in time is crucial for our success
  • Proper documentation and record keeping are essential, but they are time-consuming and resource-intensive
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"Before we started working with EXTEDO, the tasks cost more person-hours. EXTEDO's applications increase the efficiency of submission activities, improve pharmacovigilance efficiency, and provide excellent experience in multinational NDA submission."
General Manager, T-TOP Clinical Research Co., Ltd. Taiwan

Some of our Customers

aspen
Galepharm AG
Product Life Group(PLG)
Medi Radiopharma
Global Pharma Solutions

Contact us

eDOCSmanager_cara

EXTEDO eDOCSmanager

The eDOCSmanager app is a secure document management system for Life Sciences. Regulatory, Clinical (eTMF), Quality and SOP Management Modules are available.

Learn more about eDOCSmanager
MPDmanager_cara

EXTEDO MPDmanager

MPDmanager powered by CARA is EXTEDO’s comprehensive XEVMPD and IDMP software solution delivering a single source of truth for all ISO IDMP data. It supports you in planning and tracking of IDMP.

Learn more about MPDmanager
eCTDmanager

EXTEDO eCTDmanager

Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF, and other submission structures.

Learn more about eCTDmanager
eSUBmanager

EXTEDO eSUBmanager

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

Learn more about eSUBmanager
EURSvalidator

EXTEDO EURSvalidator

Easily validate medicinal and veterinary electronic submissions with the validator that is used by over 35 authorities worldwide, including EMA.

Learn more about EURSvalidator
SafetyEasy

EXTEDO SafetyEasy

Classify, create, review, submit and maintain pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance data and adverse event reports within a single, easy-to-use application.

Learn more about SafetyEasy
eCTDtemplates

EXTEDO eCTDtemplates

EXTEDO eCTDtemplates provide a simple way to create consistent and compliant electronic Common Technical Document (eCTD) dossiers.

Learn more about eCTDtemplates

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