EXTEDO

EXTEDO is a global provider of regulatory information management (RIM) software for the pharmaceutical and life sciences industry, founded in 1996 and headquartered in Ottobrunn, Bavaria, Germany. With 25+ years of operation, EXTEDO serves 700+ customers in 57–65 countries, managing over 1 million regulatory submissions through its flagship platform, EXTEDOpulse. Customer retention is 98%+ over the last five years.

EXTEDO's primary product, EXTEDOpulse, is a comprehensive RIM platform consisting of 5 integrated hubs: Registration Hub (product registration lifecycle management), Document Hub (regulatory document management), Submission Hub (dossier compilation and publishing with 50%+ faster compilation times), Safety Hub (pharmacovigilance and safety reporting), and Quality Hub (quality event management). The platform supports all major global regulatory submission formats including eCTD v3, eCTD v4, NeeS (Japan), ACTD (Asia-Pacific), eCopy (Canada), IMPD, PIP, VNeeS (veterinary), DMF, ASMF, and Clinical Trial Applications.

35+ regulatory agencies worldwide have adopted the platform, including the European Medicines Agency (EMA) — 70%+ of all eCTD-accepting regulatory authorities globally. The company has 117 employees (51–200 range) across 4 continents. EXTEDO maintains 1000+ customers with ongoing platform maintenance and support.

EXTEDO was acquired by Bertelsmann India Investments in February 2024. The company partners with Veeva for RIM system integration and has incorporated generative AI capabilities for real-time document chat and analysis.

EXTEDO is exclusively focused on pharmaceutical and life sciences regulatory information management. All 700+ customers are pharmaceutical, biotechnology, or life sciences companies requiring regulatory submission capabilities. The company does not serve other industries: 100% pharma/biotech/life sciences focus for 25+ years.

EXTEDO maintains 1000+ customers globally with 98%+ retention over the last five years. Specific customer names are undisclosed. The company's adoption by 35+ regulatory agencies worldwide, including the European Medicines Agency, represents 70%+ of all eCTD-accepting authorities.

The company serves pharmaceutical companies across 57–65 countries, spanning Big Pharma, mid-size pharma, biotech companies, and contract development and manufacturing organisations (CDMOs) operating globally. EXTEDOpulse supports all major regulatory submission formats (eCTD v3/v4, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications), covering regulatory footprints across FDA (US), EMA (EU), PMDA (Japan), NMPA (China), Health Canada, and other global regulatory authorities.

Financial information is undisclosed; EXTEDO is a private company. Bertelsmann India Investments acquired EXTEDO in February 2024.

EXTEDO reports 700+ customers, 1000+ maintained customers, 1M+ submissions managed, and 98%+ customer retention over the last five years. It has operated for 25+ years, with adoption by 35+ regulatory agencies worldwide, representing 70%+ of eCTD-accepting authorities.

EXTEDO's flagship product is EXTEDOpulse, a comprehensive regulatory information management (RIM) platform consisting of 5 integrated hubs: Registration Hub (product registration lifecycle management across global markets), Document Hub (regulatory document management with version control and content reuse), Submission Hub (automated dossier compilation and submission publishing with 50%+ faster compilation times), Safety Hub (pharmacovigilance and safety reporting), and Quality Hub (quality event management for post-market surveillance).

The platform employs a modular hub-based architecture allowing customers to deploy individual hubs or the complete integrated suite based on their regulatory needs. EXTEDOpulse supports all major global regulatory submission formats including eCTD v3, eCTD v4, NeeS (Japan), ACTD (Asia-Pacific), eCopy (Canada), IMPD (EU investigational medicinal product dossiers), PIP (pediatric investigation plans), VNeeS (veterinary), DMF (drug master files), ASMF (active substance master files), and Clinical Trial Applications. Key innovations include generative AI capabilities for real-time document chat and analysis, enabling faster document review and compliance checking. The platform has managed 1M+ submissions across 35+ regulatory agencies globally, representing 70%+ of all eCTD-accepting authorities worldwide.

EXTEDO partners with Veeva for RIM system integration, enabling data exchange between EXTEDOpulse and Veeva Vault RIM systems. The partnership serves pharmaceutical companies using Veeva's commercial and clinical platforms that also require regulatory submission capabilities.

35+ regulatory agencies worldwide have adopted the platform, including the European Medicines Agency (EMA) — 70%+ of all eCTD-accepting authorities globally. Specific technology infrastructure partners (cloud providers, implementation partners, industry affiliations) are undisclosed.

EXTEDO has 117 employees across 4 continents. The company maintains 1000+ customers with 98%+ customer retention over the last five years, and serves 700+ active customers in 57–65 countries.

Support availability (24/7 coverage, languages supported), professional services offerings (implementation, validation assistance, training programmes), customer success programmes, user community events, and certification programmes are undisclosed.

35+ regulatory agencies worldwide have adopted the platform, including the European Medicines Agency (EMA) — 70%+ of all eCTD-accepting regulatory authorities globally.

EXTEDO has operated for 25+ years (founded 1996), reports 98%+ customer retention over the last five years, and has managed 1M+ submissions. Bertelsmann India Investments acquired the company in February 2024. No ISO 9001, ISO 27001, or SOC 2 certification, analyst recognition, leadership team detail, or industry award is disclosed.

EXTEDO has 700+ customers and 1000+ maintained customers globally in the regulatory information management sector. 70%+ of eCTD-accepting regulatory authorities worldwide have adopted the platform.

Bertelsmann India Investments acquired the company in February 2024. EXTEDO has operated for 25+ years with 98%+ customer retention. Marketing content, social media presence, press release frequency, and public visibility are undisclosed.