EXTEDO. Redefining Regulatory Information Management.
  • eRA 2015 Conference, 01-02 July 2015

    Next Generation of Regulatory Information Management will be the motto of eRA 2015, which will be held in Munich, Germany. About 25 high-level experts from the industry and regulatory authorities will share their experiences and knowledge with you.

  • Regulatory Information Management

    The EXTEDOsuite is unique in that it covers the complete regulatory landscape including: product registration planning & tracking, submission management, pharmacovigilance management and document management.

  • Reviewing & Validation

    EXTEDOs reviewing and validation solutions EURS, GLOBALvalidator and EURSvalidator with their constant improvements and updates, always reflect the latest developments and help keep growing regulatory complexity under control.

  • Submission Publishing & Management

    eCTDmanager enables you to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures easily.

  • Happy customers make us happy!

  • XEVMPD Data Base System

    MPDmanager 2014 provides the functionality of a central product data repository and enables you to manage and maintain XEVMPD data efficiently and in compliance with current regulatory requirements.

About EXTEDO

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). EXTEDO’s focus is on optimizing clients’ eRegulatory business processes. The company’s enabling technology, the EXTEDOsuite, is unique in that it covers the complete regulatory landscape including:

  • Product Registration Planning & Tracking (XEVMPD & IDMP)
  • Submission Publishing & Lifecycle Management (eCTD, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex)
  • Pharmacovigilance Management (SUSAR, ICSR, PSUR, E2B, MedDRA, SMQ, GvP, CIOMS, MedWatch, R3) and
  • Document Management

We offer configurable off-the-shelf products, as well as customized and integrated solutions compliant with Medical Product Dictionary. EXTEDO also provides EURS, the validation, review and approval software solution for the EMA and over 25 Regulatory Authorities worldwide.

Today we serve more than 700 customers in 60 countries ranging from small companies to large multinational organizations.  EXTEDO operates in the following areas of life sciences: pharmaceutical, biotech and biopharma, generics, homeopathics, medical devices, crop sciences and public sector. 

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

10 Reasons to partner with EXTEDO

  1. EXTEDO has a 15+ year proven track record of success serving the life sciences industry by consistently following a customer focused approach.
  2. EXTEDO supports a global user community including more than 25 regulatory authorities and over 700 Life Sciences organizations worldwide.
  3. EXTEDO products combine innovation with compliance and quality with usability.
  4. EXTEDO provides a complete range of products and services, designed to work both as standalone solutions, as well as integrated pieces, streamlining the entire product lifecycle within eRegulatory Affairs and reducing the time to market.
  5. EXTEDO solutions can be deployed rapidly (installation, validation & training take minimal time) and can be integrated with leading technology platforms resulting in the total cost of ownership being substantially reduced.
  6. EXTEDO understands that meeting the needs of the business user is the key element to achieving a fast and reliable Return on Investment (ROI).
  7. EXTEDO is a Microsoft Gold Application Development competency partner and is certified by TÜV SÜD under the ISO9001: 2008 standard for design, implementation and distribution of document management systems, IT-solutions and associated services for life sciences organizations.
  8. EXTEDO’s global partner network serves our customers’ local needs both from a service and product perspective.
  9. EXTEDO provides expert services to the life sciences industry by combining regulatory affairs knowledge with technological expertise. Our Regulatory Competence Center (RCC) and customer support team consistently achieve high marks in customer satisfaction.
  10. EXTEDO hires the most experienced subject matter experts in their fields and, via our highly regarded training program, ensures that our experts’ skills are continuously kept current in the fast paced world of technology and regulatory affairs.

EXTEDO in the Cloud