Regulatory

Regulatory Operations for the Digital Age

Transform operations with digitization solutions for better compliance, efficiency, and real-time decision-making

Regulatory Business Problems We Help You Solve

Ensure GxP compliance by leveraging USDM’s expertise in the regulatory domain for life sciences. Enhance operational efficiency through workflow automation, data integrity solutions, and efficient submission management. Achieve faster market readiness and maintain continuous compliance with advanced validation, audit readiness, and tailored cloud and hybrid solutions.

Data Integrity and Real-Time Audit Readiness

Increase compliance and operational inefficiency with unified systems and automated processes.

Complex Regulatory Compliance Across Geographies

Navigate evolving regulatory requirements and avoid fragmented compliance processes.

Post-Market Surveillance and Reporting

Monitor product performance and adverse events across diverse markets and gather large volumes of data from multiple sources.

Unmatched Industry Expertise

Our deep experience in pharma/biotech, medical device, patient journeys, and digital technologies, including artificial intelligence and machine learning, help transform the R&D process, accelerate compliant device software development, and enhance patient experiences and outcomes.

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 >>>

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. Learn more >>>

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 Clinical Technologies

Regulatory domain services to ensure best in class compliance

Life Sciences Regulatory Domain Capabilities

Save time and money with capabilities offered by USDM, which include:

Regulatory System Validation: Ensuring that regulatory systems, such as submission management tools and eCTD systems, meet compliance standards, including FDA, EMA, GxP, and ISO requirements.
Data Integrity for Regulatory Submissions: Supporting the integrity of data used in regulatory submissions to ensure accuracy, traceability, and consistency across the entire submission lifecycle.
Regulatory Workflow Automation: Automating regulatory workflows, such as submission approvals, document reviews, and change control, to reduce manual effort, minimize errors, and accelerate submission timelines.
Risk-Based Regulatory Management: Implementing risk-based approaches to proactively address compliance issues and deviations before they impact product approval or market access.
System Integration and Interoperability: Integrating regulatory systems with other enterprise tools, such as QMS and document management systems, ensuring seamless data flow and collaboration across departments.
Cloud Assurance for Regulatory Systems: Providing continuous compliance for cloud-based regulatory systems with USDM’s Cloud Assurance, ensuring ongoing audit readiness and adherence to regulatory standards.
Regulatory Data Security: Implementing security protocols to protect regulatory data, ensuring compliance with regulations like GDPR, HIPAA, and GxP standards.
Change Management and User Training: Managing change initiatives and providing training to support effective adoption of new regulatory systems, policies, and workflows.
GxP Compliant DevOps for Regulatory Applications: Developing compliant DevOps frameworks for regulatory applications to streamline development, ensure GxP adherence, and support regulatory submissions.
Regulatory Documentation Optimization: Supporting the implementation and optimization of regulatory documentation systems, ensuring effective management and compliance of submission records and SOPs.
Standard Operating Procedure (SOP) Development: Developing SOPs to ensure compliant and consistent regulatory processes aligned with global standards.
Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing regulatory systems and vendors to ensure compliance, integration, and optimal performance.
System Design, Implementation, Validation, and Release Management for:
- Electronic Common Technical Document (eCTD)
- Submission Management System
- Document Management System (DMS)
- Training Management System
- Deviation and Change Control Management
- Risk Management Platforms
- Regulatory Information Management (RIM)
- Secure Data Servers and more