Domains
Regulatory Solutions for the Digital Age
Transform operations with digitization solutions for better compliance, efficiency, and real-time decision-making
Empower your regulatory team with transformative digitization solutions that drive compliance, streamline submissions, and support real-time, informed decision-making.
Data Integrity and Real-Time Audit Readiness
Enhance compliance and operational efficiency with unified data systems and automated audit processes, ensuring accurate records and complete traceability for audit readiness and regulatory submissions.
Complex Regulatory Compliance Across Geographies
Navigate complex, evolving regulatory requirements across multiple regions while ensuring consistent compliance. Avoid fragmented processes with a strategic, global regulatory approach for streamlined operations.
Post-Market Surveillance and Reporting
Monitor product performance and adverse events across diverse markets and gather large volumes of data from multiple sources.
Automate Regulatory Documentation
USDM’s life sciences regulatory solutions are purpose-built to automate regulatory documentation, accelerate submissions, and enhance compliance. From regulatory intelligence to regulatory writing and consulting, our tools support life science regulatory compliance, streamline processes, and ensure audit readiness. Achieve operational efficiency while meeting global FDA regulations and documentation standards.
Unmatched Industry Expertise
With unmatched industry expertise, USDM delivers tailored solutions that modernize compliance and technology, ensuring seamless regulatory adherence while optimizing processes and driving operational excellence. We empower life sciences companies to achieve their most ambitious goals, bringing transformative therapies to market and helping humans thrive.
Pharmaceuticals
Biologics & Biotechnology
Medical Device & SaMD
CRO/CMO
Other
Life Sciences Use Cases
Data Integration for Comprehensive Regulatory Oversight
Integrate regulatory, quality, and safety data into a unified framework for complete oversight. USDM ensures data interoperability, regulatory traceability, and real-time insights. Learn more about our solutions.
Efficient Change Control for Regulatory Updates
Maintain compliance across systems with a structured change control process. USDM automates change documentation, risk assessments, and audit trails for seamless regulatory updates. Learn more.
Resource-Intensive Submission Processes
Automate submission processes and simplify eCTD platforms to accelerate product launches. USDM integrates document management systems to ensure compliance and reduce manual workload. Learn more.
Impact on Time to Market
Enable agile development and compliance to speed time to market. USDM provides integrated quality, compliance systems, real-time analytics, and regulatory automation for efficiency. Read the blog.
Post-market Monitoring and Product Safety
Simplify safety monitoring and prevent recalls with proactive surveillance. USDM integrates IoT, advanced analytics, and safety management for effective post-market monitoring. Learn more.
Change Management and User Training for New Technologies
Adapt manufacturing workflows to new technologies with USDM’s change management and training, ensuring smooth adoption and digital readiness. Learn more.
Life Sciences Regulatory Technologies
Regulatory consulting services to ensure best in class compliance
Leveraging advanced regulatory intelligence
Process, Compliance & Quality Management Services
- Risk-Based Regulatory Management: Proactively manage deviations and compliance issues before they impact product approval or market access.
- Standard Operating Procedure (SOP) Development: Create globally aligned SOPs to support consistent, compliant regulatory operations.
- Regulatory Documentation Optimization: Improve management of submission records and SOPs to maintain integrity and compliance.
- Regulatory Data Security: Apply advanced data protection protocols to meet GDPR, HIPAA, and GxP requirements.
- Change Management and User Training: Drive successful adoption of new regulatory systems and processes through structured training and OCM strategies.
- Vendor and System Evaluations, Selection, and Management: Select and manage regulatory technology vendors with a focus on compliance, integration, and performance.
Technology-Driven Regulatory Services
- Regulatory System Validation: Validate tools like eCTD and submission management systems to meet FDA, EMA, GxP, and ISO requirements.
- Regulatory Workflow Automation: Automate document reviews, submission approvals, and change control to accelerate timelines and reduce errors.
- System Integration and Interoperability: Connect regulatory systems with QMS, DMS, and other enterprise tools for seamless collaboration.
- Cloud Assurance for Regulatory Systems: Ensure continuous GxP compliance and audit-readiness of cloud-hosted regulatory platforms with USDM’s proprietary framework.
- GxP-Compliant DevOps for Regulatory Applications: Enable faster, secure development and deployment of regulatory software in a fully compliant DevOps environment.
- Data Integrity for Regulatory Submissions: Maintain accuracy, traceability, and consistency across the submission lifecycle.
- System Design, Implementation, Validation, and Release Management:
- eCTD
- Submission Management Systems
- Document Management Systems (DMS)
- Training Management Systems
- Deviation & Change Control Management
- Risk Management Platforms
- Regulatory Information Management (RIM)
- Secure Data Servers and more
Life Science Regulatory Compliance FAQ
Global life science regulatory compliance requires adherence to FDA regulations, EMA guidelines, ICH standards, ISO certifications, and country-specific rules. USDM’s life sciences regulatory solutions and regulatory intelligence tools help organizations navigate evolving global frameworks, streamline processes, and automate regulatory documentation to maintain continuous compliance worldwide.
To automate regulatory documentation workflows for FDA submissions, use USDM’s advanced life sciences regulatory solutions. Our tools integrate regulatory intelligence, streamline content creation, and ensure life science regulatory compliance. Gain efficiency, reduce errors, and maintain audit readiness with AI-driven processes and expert regulatory support.
Organizations ensure data integrity across the submission lifecycle by leveraging USDM’s life sciences regulatory solutions. Our platforms enforce structured controls, enable regulatory intelligence, and automate regulatory documentation to maintain accuracy, traceability, and life science regulatory compliance from creation to submission—supporting global standards and FDA regulations.
Automation enhances life science regulatory compliance by reducing manual errors, accelerating processes, and maintaining audit readiness. USDM’s life sciences regulatory solutions leverage AI to automate regulatory documentation, enable real-time regulatory intelligence, and ensure alignment with FDA regulations, improving efficiency and supporting global regulatory compliance intelligence initiatives.
To prepare for audits and inspections, companies should implement USDM’s life sciences regulatory solutions to ensure continuous life science regulatory compliance. Leverage regulatory intelligence, maintain a centralized regulatory database, and automate regulatory documentation to stay audit-ready, meet FDA regulations, and streamline global inspection processes with confidence.
USDM delivers assurance and continuous life science regulatory compliance through its trusted life sciences regulatory solutions. Our experts leverage regulatory intelligence, automation, and AI to monitor systems, automate regulatory documentation, and align with FDA regulations, ensuring your regulatory systems remain secure, audit-ready, and globally compliant at all times.
When selecting and validating regulatory information management systems, consider life science regulatory compliance, integration with regulatory intelligence tools, data security, and the ability to automate regulatory documentation. USDM’s life sciences regulatory solutions ensure alignment with FDA regulations and provide scalable support for global regulatory operations.
Streamline workflows, secure data, and accelerate submissions. Ready to enhance operations?
