Frost Radar(TM) : 생명과학 규제 정보 관리 플랫폼(2026년)

The regulatory technology market in life sciences has, over the last five years, quietly transformed from a back-office category dominated by document repositories and submission publishing tools to one of the most consequential software segments serving the pharmaceutical, biotech, and medical device industries. What started in the late 1990s as a niche set of tools to assemble eCTD dossiers has evolved into a multibillion-dollar landscape of cloud platforms, AI-enabled authoring tools, regulatory intelligence engines, and integrated information management suites that sit at the center of how a drug or device moves from filing to global registration. Regulatory information management (RIM) platforms have become central to how regulatory functions respond. They bring capabilities that used to sit in separate systems—registration and product tracking, submission planning and publishing, document management, health authority interaction management, labeling, and regulatory data intelligence—into a connected environment. What companies are looking for is a dependable single view of their regulatory data, processes that run end to end without manual rekeying, and readiness for the data standards that regulators are steadily introducing. More recently, AI and agentic capabilities are entering these platforms, though maturity varies widely between vendors and much of what is promoted remains at an early stage. For the purposes of this Frost Radar, regulatory technology in life sciences encompasses the software, platforms, and tech-enabled services that help pharmaceutical, biotech, and generics companies plan, prepare, submit, track, and maintain regulatory filings with health authorities; manage the underlying product, registration, and submission data; and demonstrate compliance with applicable regulations across global markets. That definition deliberately includes pure-play software vendors, hybrid consulting-plus-technology firms, and enterprise platforms whose regulatory modules sit alongside quality, clinical, or manufacturing capabilities.

Frost & Sullivan analyzes numerous companies in an industry. Those selected for further analysis based on their leadership or other distinctions are benchmarked across 10 Growth and Innovation criteria to reveal their position on the Frost Radar™. The publication presents competitive profiles of each company on the Frost Radar™, considering their strengths and the opportunities that best fit those strengths.

Strategic Imperative and Growth Environment

Frost RadarTM: Life Sciences Regulatory Information Management Platforms

Companies to Action

• AmpleLogic
• ArisGlobal
• DDi
• DXC Technology
• Ennov
• EXTEDO
• Freyr
• Generis
• IQVIA
• LORENZ Life Sciences
• Veeva

Best Practices & Growth Opportunities

Frost RadarTM Analytics

Next Steps: Leveraging the Frost RadarTM to Empower Key Stakeholders

• Significance of Being on the Frost RadarTM
• CEO's Growth Team
• Investors
• Customers
• Board of Directors

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