Celegence

Overview

Celegence LLC is a regulatory affairs services and solutions provider based in Chicago, founded in 2017 by Sonia Veluchamy and Punya Abbhi. Specializing in enhancing regulatory compliance and operational efficiency for life sciences companies, the organization supports clients in pharmaceuticals, medical devices, and in vitro diagnostics. Operating globally, Celegence maintains offices in the United States, United Kingdom, Netherlands, Romania, and India.

The organization offers a suite of tech-driven regulatory services throughout the product lifecycle, including regulatory affairs consulting, regulatory publishing, medical and technical writing, and compliance support. Proprietary technologies like the CAPTIS® AI platform for automating medical writing and compliance, as well as Dossplorer™ and Dosscriber™ for dossier management and document authoring, enable streamlined regulatory processes and effective compliance strategies. With a strong focus on AI and automation, Celegence helps clients achieve efficient compliance and successful product launches.

Basic Information

Contact Details

• Phone: +1 331-207-4661
• Website: celegence.com
• LinkedIn: linkedin.com/company/celegence

Key Focus Areas & Initiatives

• Business consulting & services
• Automated document authoring
• Regulatory reporting tools
• Regulatory expertise
• Regulatory intelligence platform
• AI-powered platform
• Regulatory submission management
• Product lifecycle management
• Document automation
• Regulatory data governance
• Consulting
• Regulatory compliance tools
• Regulatory document management
• Other scientific and technical consulting services
• Regulatory operations
• Regulatory support
• Regulatory reporting
• Data management
• Regulatory submissions
• Product lifecycle support
• Regulatory industry
• Regulatory documentation
• Regulatory compliance
• B2B
• Regulatory standards
• Regulatory data standardization
• Regulatory strategy consulting
• Cloud-based dossier management
• Regulatory technology
• Regulatory data management
• Regulatory process automation
• Life sciences
• Product development
• Regulatory solutions
• Regulatory intelligence
• Regulatory strategy
• Risk management
• Regulatory compliance software
• Regulatory submission tracking
• Regulatory publishing
• Regulatory data migration
• Pharmaceutical
• AI-powered regulatory compliance platform
• Regulatory document review automation
• Regulatory lifecycle
• Regulatory document automation
• Dossier management
• Regulatory consulting
• Regulatory process optimization
• Healthcare
• Regulatory project management
• Regulatory compliance automation
• Regulatory process automation tools
• Regulatory consulting services
• Medical device
• eCTD submissions
• Regulatory data analytics
• Regulatory workflow
• Medical writing
• Regulatory process optimization tools
• Regulatory services
• Regulatory intelligence solutions
• Operational efficiency
• Regulatory document management system
• Regulatory data standards
• Regulatory affairs
• Pharmaceutical consulting
• Medical device consulting
• Post market surveillance
• Clinical evaluation reports
• IDMP compliance
• Regulatory affairs consultancy
• Regulatory labeling
• CMC technical authoring
• UDI consulting
• Submission management
• Learning management systems
• MDR compliance
• IVDR consulting
• Global regulatory strategies
• Strategic support services
• Compliance framework
• Regulatory submission strategies
• Regulatory dossier management
• Clinical trial authorization
• Risk management plans
• Periodic benefit risk evaluation reports
• ISO standards compliance
• Data collection services
• Submission templates
• Cross-industry consulting
• Regulatory operations management
• Regulatory insights
• Patient safety compliance
• Medical device regulations
• Pharmaceutical industry standards
• Data governance
• Pharmacovigilance services
• Regulatory training programs
• Market authorization consulting
• Dossplorer viewer
• eCTD document templates
• Combination products consulting
• Global regulatory insights
• Compliance readiness assessments
• Systematic literature reviews
• Data migration services
• Management consulting
• Medical
• Health care
• Health, wellness & fitness
• Hospital & health care

Technologies Used

• Amazon AWS
• Amazon SES
• Apache
• Clicky
• DoubleClick
• DoubleClick Conversion
• Google Analytics
• Google Dynamic Remarketing
• Google Font API
• Google Tag Manager
• Gravity Forms
• Hubspot
• Linkedin Marketing Solutions
• Microsoft Office 365
• Mobile Friendly
• Outlook
• Pardot
• React Redux
• Route 53
• Salesforce
• SendInBlue
• Slack
• WordPress.org
• reCAPTCHA

Affiliated Organizations & Regional Branches

• Qdossier