EXTEDO

EXTEDO is a regulatory information management (RIM) software and services company serving the life sciences industry. Founded in 1996 and headquartered in Germany with additional offices in Croatia and the USA, the company develops solutions that help pharmaceutical manufacturers, contract research organizations (CROs), and regulatory agencies manage regulated documents, data, and processes throughout the medicinal product lifecycle. Since February 2024, EXTEDO has been part of Bertelsmann Group's Digital Health division. The company reports more than 1,000 customers across 65 countries and a customer retention rate above 98% over the last five years.

EXTEDO's end-to-end platform, EXTEDOpulse, covers master data management, document management, registration management, submission management, and safety management. The applications can be used individually or in combination. EXTEDO also provides a range of professional services alongside its software, including regulatory publishing, pharmacovigilance support, IDMP services, technical consulting, education and training, and validation services.

EXTEDOpulse Software Hubs

• Document Management Hub: Manages regulated documents, including a DMS Regulatory module and eCTD templates.
• Registration Management Hub: Supports the management of product registrations across geographic regions and regulatory jurisdictions.
• Submission Management Hub: Covers submission publishing, viewing, reviewing, and validation to support the preparation and handling of regulatory submissions.
• Safety Management Hub: Addresses pharmacovigilance and patient safety data management requirements.
• Quality Management Hub: Supports quality management processes within the regulated pharmaceutical environment.

Professional and Consulting Services

• Regulatory Publishing Services: Outsourced publishing support for regulatory submissions.
• Business Process and Regulatory Consulting: Advisory services covering regulatory strategy and process design.
• Pharmacovigilance Services: Support for safety reporting and pharmacovigilance obligations.
• eCTD Services: Specialist services related to electronic Common Technical Document submissions.
• Agency Services: Solutions and services tailored specifically for regulatory authorities.
• IDMP Services: Support for Identification of Medicinal Products standards compliance.
• Technical Consulting: Implementation and system integration support.
• Education and Training: Training programs covering regulatory processes and EXTEDO software.
• Validation Services: Computer system validation support for regulated environments.
• Extended Support Services: Ongoing operational and technical support for deployed solutions.

Customer Segments

• Large life sciences companies: EXTEDO supports large organizations managing hundreds of products across multiple geographic regions and regulatory jurisdictions.
• Small and medium-sized businesses and CROs: Off-the-shelf software and services are available for smaller organizations and contract research organizations, designed around common business and regulatory needs.
• Regulatory agencies: EXTEDO's reviewing and validation solutions are used by more than 35 regulatory agencies worldwide, including the European Medicines Agency, most local European National Competent Authorities, and Swissmedic.

Key Metrics and Capabilities

• More than 1 million submissions managed using EXTEDO solutions.
• Over 70% of all eCTD-accepting authorities worldwide use EXTEDO solutions or services.
• Submission compilation reported to be more than 50% faster due to intelligent automation.
• The company employs more than 100 staff representing over 20 nationalities.
• EXTEDO team members participate in local standards committees and ISO groups involved in defining regulatory standards.
• The company conducts regular audits and certifications and holds memberships in relevant industry organizations.

EXTEDO has operated in the eRegulatory space for over 25 years and positions its platform as a complete solution for life sciences organizations seeking to reduce the time, cost, and complexity associated with regulatory compliance across the full product development and post-market lifecycle.