Use your resources in a structured and effective way
Make your business processes more efficient and safer
Stay compliant with the latest international regulations
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
Some of our Customers
The eDOCSmanager app is a secure document management system for Life Sciences. Regulatory, Clinical (eTMF), Quality and SOP Management Modules are available.
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.
Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF, and other submission structures.
Reduce the complexity of viewing and reviewing archived and in-progress electronic submissions.
Easily validate medicinal and veterinary electronic submissions with the validator that is used by over 35 authorities worldwide, including EMA.
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.