Comprehensive regulatory information management (RIM) platform with 5 integrated hubs managing 1M+ submissions across 35+ regulatory agencies globally, serving 700+ customers in 57-65 countries with 98%+ retention rate.
EXTEDO EXTEDOpulse is a comprehensive regulatory information management (RIM) platform serving pharmaceutical and life sciences companies globally since 1996. With 25+ years of operation, the platform manages 1M+ regulatory submissions across 700+ customers in 57-65 countries, achieving 98%+ customer retention over the last 5 years. The platform is adopted by 35+ regulatory agencies worldwide, including the EMA, representing 70%+ of all eCTD-accepting authorities globally.
The platform consists of 5 integrated hubs: Registration Hub for product registrations and lifecycle management, Document Hub for regulatory document management, Submission Hub for dossier compilation and submission publishing (50%+ faster than manual processes), Safety Hub for pharmacovigilance and safety reporting, and Quality Hub for quality event management. This unified architecture provides end-to-end regulatory lifecycle management from initial registration through post-market surveillance.
EXTEDOpulse supports all major 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. The platform includes generative AI capabilities for real-time document chat and analysis, enabling faster document review and compliance checking. Integration partnerships include Veeva for data exchange with RIM systems.
The platform serves 1000+ maintained customers globally, with 117 employees (51-200 range) across four continents. EXTEDO is privately held, acquired by Bertelsmann India Investments in February 2024, and has operated in regulatory submission management for 25+ years.
Pharmaceutical Edition
EXTEDO EXTEDOpulse is purpose-built exclusively for pharmaceutical and life sciences regulatory information management. All 700+ customers are pharmaceutical, biotechnology, or life sciences companies requiring regulatory submission management. The platform architecture, submission formats (eCTD, NeeS, ACTD, IMPD, etc.), and 5 integrated hubs (Registration, Document, Submission, Safety, Quality) are designed specifically for pharma regulatory compliance and FDA/EMA/global regulatory authority requirements.
Core Capabilities
FDA & GxP Compliance
Data Integrity & Validation
Deployment model (cloud/SaaS or on-premise), hosting architecture and infrastructure specifications are undisclosed. The platform comprises five integrated hubs - Registration, Document, Submission, Safety, Quality - and integrates with Veeva RIM systems through a partnership. It supports eCTD v3/v4, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF and Clinical Trial Application formats, and includes generative AI for document chat and analysis.
Pricing is undisclosed: no list price, pricing model (subscription or perpetual licence), pricing structure (per-user, site-based or submission-based) or typical deal size is published. EXTEDO is privately held, acquired by Bertelsmann India Investments in February 2024, and reports no public financial details. Free trial and demo availability are undisclosed. No self-serve pricing route exists; pricing is obtained by contacting EXTEDO sales directly.
Implementation timeline, validation assistance, data migration capabilities and training programmes are undisclosed. The company operates globally, with 117 employees across four continents. It serves 700+ customers with 98%+ retention over the last five years and 1000+ maintained customers overall.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
No review platform lists this product. Reported metrics: 98%+ customer retention over the last five years, 700+ customers globally, 1000+ maintained customers, adoption by 70%+ of eCTD-accepting regulatory authorities worldwide, 50%+ faster submission compilation, and 25+ years of operation.
Limitations & Open Questions
No review platform lists this product, so no user-reported pain points, complaints or improvement areas are documented.
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