Validation Associates
Validation Associates LLC is a leading provider of business and technology solutions focused on enhancing operational performance in the life sciences industry. They specialize in validation, compliance, and regulatory consulting, offering services that include validation project management, quality system consultation, clinical study compliance, and validation strategies. With a strong emphasis on regulatory standards such as FDA regulations and GAMP 5, they serve clients in pharmaceuticals, biotech, and medical devices, delivering innovative and flexible solutions to meet their clients' validation and compliance needs. Their mission is to ensure that their clients achieve their IT and business objectives in a professional, timely, and cost-effective manner, with a commitment to quality, client service, and regulatory compliance.
Industries
Nr. of Employees
medium (51-250)
Validation Associates
131 Elden St #302, Herndon, VA 20170, USA
Services
Consulting engagements covering validation strategy, protocol development, execution of IQ/OQ/PQ, test scripting, documentation and summary reporting to meet regulatory requirements.
Gap analysis, quality program development, GMP/QSR advisory, FDA readiness audits, and implementation support for quality and compliance systems.
Services supporting clinical compliance including GCP/GLP assessments, clinical operations support (investigator/sponsor/monitor roles), and clinical data management support.
Provision of validated subject-matter experts and consulting teams to augment client staff for validation, quality, regulatory and clinical programs.
Consulting engagements covering validation strategy, protocol development, execution of IQ/OQ/PQ, test scripting, documentation and summary reporting to meet regulatory requirements.
Gap analysis, quality program development, GMP/QSR advisory, FDA readiness audits, and implementation support for quality and compliance systems.
Services supporting clinical compliance including GCP/GLP assessments, clinical operations support (investigator/sponsor/monitor roles), and clinical data management support.
Provision of validated subject-matter experts and consulting teams to augment client staff for validation, quality, regulatory and clinical programs.
Expertise Areas
- Computerized system validation
- Validation project management
- Regulatory compliance and GxP systems
- Quality systems and GMP/QSR consulting
Key Technologies
- Computerized system validation (CSV)
- Risk-based validation frameworks
- GxP quality management systems
- IQ/OQ/PQ protocol development and execution