Navigate intricate regulations for multiple
products across regions
Connect your team in a single platform and reduce information silos
Minimize compliance risks and accelerate time-to-market
Are your products taking longer to reach market due to regulatory complexities?
Mastering global regulatory tasks in a multinational life science organization requires the right strategies
- Staying up-to-date with international regulations and new standards is a complex and ongoing concern
- Allocating and controlling resources efficiently is a constant struggle for me
- We lack a robust strategic structure to effectively expand and compete in the market
- I'm dealing with a massive volume of documents and data, which can be overwhelming to manage efficiently
- I need better ways to handle the increasing volume and size of incoming submissions
- Collaborating on submissions across different teams and regions can be challenging
“EXTEDO is known for the knowledge of the relation with the regulatory agencies. So it was one of our first choices when we decided to move to another vendor.
We know that eCTD 4.0 is coming. We know that EXTEDO is working on that. We know that they are very capable of those situations, so we rely on them.”
Ana Verónica Mak, Associate Director of the Publishing Team, Parexel
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.