About us

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management.

The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs:

• Product Registration Planning & Tracking
• Submission Management, (eCTD, CTD, NeeS, CADDY,  ePRISM, eIndex, eNTA, vNeeS)
• Pharmacovigilance Management (SUSAR, ICSR, PSUR, E2B)
• Labeling Management and
• Document Management

We provide configurable Off-the-Shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today we serve more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multinational organizations. 

EXTEDO operates in the following areas of life sciences: pharmaceutical, biotech and biopharma, generics, homeopathics, medical devices, healthcare, and public sector.

EXTEDO is recognized as one of the worldwide leaders in each of our areas of operation.