Raland Technologies, LLC
Raland Compliance Partners is a full-service consulting firm supporting life science companies from product concept to commercialization, focusing on providing quality, regulatory, and compliance solutions. They foster partnerships with clients, industry leaders, and employees to deliver value-added solutions and stay on top of regulatory trends. Headquartered in Chicago, IL, with offices across the US and representative locations nationwide, they serve the pharmaceutical, biotech, and medical device industries. Their services include regulatory support, GxP compliance, validation, project management, training, translation, and more, with a mission to support patient safety and regulatory excellence.
Industries
Nr. of Employees
medium (51-250)
Raland Technologies, LLC
Products
Proprietary learning management system (LMS)
A unified-code-base LMS designed to operate on web, LAN, and standalone environments to deliver and manage e-learning and performance support.
Proprietary learning management system (LMS)
A unified-code-base LMS designed to operate on web, LAN, and standalone environments to deliver and manage e-learning and performance support.
Services
Advisory services to define regulatory and compliance strategies across product development and commercialization for life science companies.
Gap assessments, inspection readiness, mock inspections, supplier audits, and quality systems improvement programs to optimize regulatory compliance.
Validation and remediation of computerized systems in regulated environments, including protocol development, execution, and reporting.
End-to-end C&Q services for utilities, equipment, and facilities including planning, FAT/SAT support, IQ/OQ/PQ protocol development and execution.
Program and project management for validation programs, new facilities, capital projects, vendor management, and PMO activities.
Regulatory strategy and submission support for drug and device applications, and guidance on international regulatory requirements including EU MDR.
Advisory services to define regulatory and compliance strategies across product development and commercialization for life science companies.
Gap assessments, inspection readiness, mock inspections, supplier audits, and quality systems improvement programs to optimize regulatory compliance.
Validation and remediation of computerized systems in regulated environments, including protocol development, execution, and reporting.
End-to-end C&Q services for utilities, equipment, and facilities including planning, FAT/SAT support, IQ/OQ/PQ protocol development and execution.
Program and project management for validation programs, new facilities, capital projects, vendor management, and PMO activities.
Regulatory strategy and submission support for drug and device applications, and guidance on international regulatory requirements including EU MDR.
Expertise Areas
- GxP compliance and remediation
- Validation and commissioning (C&Q, IQ/OQ/PQ)
- Computer system validation and IT remediation
- Regulatory submissions and strategy (IND/BLA/medical device filings, EU MDR)
Key Technologies
- Commissioning, qualification, and validation methodologies
- Computer system validation (CSV)
- Learning Management Systems (LMS)
- SCORM