Ratings and Reviews 4 Ratings
Ratings and Reviews 0 Ratings
Alternatives to Consider
-
Predict360Predict360, developed by 360factors, serves as a comprehensive risk and compliance management platform designed to streamline workflows and improve reporting for various financial institutions, including banks, credit unions, and insurance companies. This cloud-based SaaS solution consolidates essential components such as regulations, compliance management, risk assessments, controls, key risk indicators (KRIs), audits, policies, and training into one cohesive platform while offering powerful analytics and insights that help clients foresee risks and enhance compliance efforts. If your current Governance, Risk, and Compliance (GRC) system isn't equipped with an effective analytics and business intelligence tool for creating insightful reports for executives and board members, consider Lumify360 from 360factors. This predictive analytics platform can seamlessly integrate with any existing GRC, allowing you to maintain your workflow processes while equipping stakeholders with the timely reports and dashboards they require for informed decision-making. With these advanced tools at your disposal, you'll be better positioned to navigate the complexities of regulatory compliance and risk management.
-
QualioQualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
-
Lockbox LIMSA cloud-based Laboratory Information Management System (LIMS) is designed to oversee sample tracking, test outcomes, and inventory management specifically for life sciences research, industrial quality control laboratories, and biotechnology/next-generation sequencing applications. This comprehensive system provides essential regulatory compliance support for standards such as CLIA, HIPAA, Part 11, and ISO 17025, ensuring that laboratories operate within the necessary legal frameworks. The importance of quality, security, and traceability in managing samples cannot be overstated, as these factors play a pivotal role in a lab's effectiveness and reliability. Utilizing the Lockbox LIMS platform, laboratory professionals gain the ability to meticulously oversee their samples, offering complete transparency throughout the entire process, from initial accession to long-term preservation. Additionally, LIMS analysis encompasses far more than merely tracking outcomes; the Lockbox system features advanced multilayered sample storage capabilities and location management, allowing users to customize their laboratory's storage framework with diverse options that include rooms, storage units, shelves, racks, and boxes. This flexibility empowers labs to efficiently organize and access their samples, ultimately enhancing operational productivity and accuracy.
-
Interfacing Integrated Management System (IMS)Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.
-
Captain ComplianceCaptain Compliance is a comprehensive privacy management solution designed to facilitate adherence to international data protection laws and emerging AI regulatory standards. Featuring a Consent Management Platform, it allows organizations to efficiently handle user consent and design personalized cookie consent banners tailored to their needs. Additionally, the platform includes an advanced Cookie Scanner that identifies and classifies all cookies present on your website, thereby guaranteeing compliance with a fluid regulatory framework. The DSAR Portal simplifies the process of handling requests from data subjects, while the AI Compliance Tool provides ongoing monitoring and adaptation to changing regulations. For those requiring expert guidance on data privacy matters, we also offer the option of a virtual Data Protection Officer or Chief Privacy Officer. Our Hosted Privacy Policy Generator ensures that your privacy policies are automatically updated in real-time, aligning them with the latest legal requirements. With Captain Compliance, you gain access to a suite of tools designed to help you maintain regulatory compliance, safeguard user data, and do so at a cost-effective rate. Ultimately, this platform empowers businesses to navigate the complexities of data privacy with confidence and ease.
-
Nasdaq MetrioNasdaq Metrio serves as a sustainability reporting platform designed to assist businesses regardless of their progress in the ESG landscape. By integrating thorough data gathering, monitoring, and management with precise emissions assessments and verification, it creates a robust solution for sustainability reporting. Furthermore, it boasts an extensive repository of metrics sourced from multiple rating and ranking frameworks, along with regulatory organizations, ensuring that all information is cross-referenced, de-duplicated, and made clear, accompanied by helpful guidance notes for users. This makes it an invaluable tool for organizations aiming to enhance their sustainability practices and compliance efforts.
-
HaastHaast is the AI engine for marketing compliance, built for enterprise marketing, legal, and compliance teams. It deploys AI agents that automate manual compliance work across the entire content lifecycle - from pre-publication review and approvals to continuous monitoring of live websites, social media, and partner channels. Unlike traditional compliance tools, Haast learns your organization’s unique risk tolerance and applies it consistently across all content, channels, and teams. This enables marketers to self-serve compliance and resolve issues before publishing, while giving legal teams faster, more reliable oversight without becoming a bottleneck. Haast analyzes text, images, PDFs, video, and web content to identify real regulatory and brand risks, providing clear, actionable fixes. It supports both pre-launch checks and always-on monitoring, helping enterprises detect issues early and reduce exposure to regulatory fines or reputational damage. Built for complex, regulated environments like financial services, retail, telecommunications and gaming, Haast adapts to internal policies, approval workflows, and evolving regulatory requirements across regions and business units. By embedding directly into end-to-end workflows, it replaces slow, manual review processes with scalable, automated compliance infrastructure. The result is faster go-to-market, reduced compliance risk, and a more efficient way for marketing and legal teams to work together.
-
MedTrainerMedTrainer streamlines and enhances the education, compliance, and credentialing processes for the healthcare workforce. Its software platform is designed for optimal user interaction, enabling healthcare organizations to effectively manage their personnel. The learning management system (LMS) tailored for healthcare offers a wealth of educational courses and materials developed by experts, ensuring that organizations meet regulatory standards and accreditation needs while providing opportunities for continuing education credits. In terms of compliance, MedTrainer provides a comprehensive technology solution that integrates incident reporting, document management, and customizable reporting to bolster adherence to regulations. Additionally, its credentialing feature offers a complete solution with automation and organized workflows, making the entire process more efficient and minimizing delays. Every aspect, from primary source verification to provider enrollment and privileging, is consolidated on a single platform, allowing for full transparency and oversight throughout. With MedTrainer, healthcare organizations can significantly reduce the complexities associated with workforce management.
-
SBS Banking PlatformSBS Banking Platform is a cutting-edge, cloud-native solution that provides financial institutions with the flexibility to scale according to their own needs, delivering seamless, digital-first experiences that can be accessed anytime, anywhere. Designed as a fully integrated, front-to-back platform, it fosters innovation across a variety of sectors, including retail banking, corporate banking, and neobanking. From digital and open banking services to deposits, payments, lending, and regulatory compliance, SBS Banking Platform equips financial institutions in the EMEA region with everything they need to stay ahead of the curve in an increasingly competitive market. By providing customizable solutions that align with the specific needs of each institution, the platform supports continuous growth and innovation. SBS Banking Platform is trusted by leading banks, earning recognition from industry giants such as Gartner, Forrester, NelsonHall, and IBS for its significant impact on the banking industry. Recent acknowledgments from Omdia for digital banking, Chartis for regulatory reporting, and NelsonHall for Cloud, SaaS & BPaaS reinforce the platform’s commitment to excellence and its position as a leader in modern banking technology. By streamlining operations and enhancing customer experiences, SBS Banking Platform is driving the future of digital banking.
-
SumsubSumsub is an all-encompassing verification platform that facilitates global customer onboarding, accelerates access, lowers expenses, and combats digital fraud effectively. By integrating robust verification processes with enhanced conversion rates across the globe, Sumsub offers a comprehensive suite tailored to diverse requirements, including KYC/AML checks, KYB verifications, payment fraud mitigation, and facial recognition authentication. This versatility not only streamlines operations for businesses but also enhances user experience, making it a preferred choice in the realm of digital verification solutions.
What is RegDesk?
RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies.
• Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates.
• With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time.
• The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions.
• Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners.
• The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards.
• Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators.
To learn more about our offerings, please explore our website.
What is GlobalSubmit?
Whether you are an experienced expert or just starting out in the realm of regulatory submissions, the threat of rejection for your electronic common technical document (eCTD) submissions is a pressing issue, especially given the growing complexity and continual changes in the regulatory environment. Additionally, the differences in eCTD submission standards across various regions, coupled with the difficulties of overseeing the entire document lifecycle, can hinder your organization’s goals of expediting market access. By leveraging Certara’s GlobalSubmit™ eCTD submissions management software, your regulatory team will gain access to essential resources for effectively publishing, validating, and reviewing eCTD submissions. This method not only helps reduce risks but also allows for a more straightforward eCTD submission workflow, which in turn enables your regulatory team to meet crucial deadlines and deliver treatments to patients efficiently. As your regulatory department continues to work hard under pressure to meet strict timelines and facilitate patient access to innovative therapies, the task of filing eCTD submissions becomes increasingly critical. Thus, it is vital to have appropriate tools and support in place to enhance your submission efficiency, significantly improving your chances of success and ultimately benefiting patient care. Moreover, investing in advanced submission management solutions can lead to smoother operations and better alignment with regulatory demands.
Integrations Supported
Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
API Availability
API Availability
Pricing Information
Contact us to learn more.
Pricing Information
Pricing not provided
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
On-Site Training
Company Facts
Organization Name
RegDesk
Date Founded
2014
Company Location
United States
Company Website
www.regdesk.co
Company Facts
Organization Name
Certara
Date Founded
2008
Company Location
United States
Company Website
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
Categories and Features
Life Sciences
Not specified
Regulatory Information Management (RIM)
Not specified
Regulatory Intelligence
Not specified
Categories and Features
Submission Management
Not specified