EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs.
The complete EXTEDOsuite is unique in all that it covers:
- Product Registration Planning & Tracking
- Submission Management (eCTD, CTD; NeeS, CADDY, ePRISM, eIndex, eNTA , vNeeS)
- Pharmacovigilance Management (SUSAR, ICSR, PSUR, E2B)
- Label Management (PIM, SPL) 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 multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection:
- Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices
- Healthcare and public sector.
EXTEDO is recognized as the worldwide leader in each of our areas of operation.
- Submission Management
- Document Management
- Pharma- covigilance Management
- Labeling Management
- Project Management
