Spgl

SPGL Regulatory Consulting and Compliance division (RCC), offers a diverse range of auditing services in various GxP areas, resulting in increased efficiency and cost savings. With a large team of highly qualified auditors, we possess extensive expertise spanning the entire development and regulatory spectrum, including renowned agencies such as the EMA, MHRA, and FDA, as well as certifications like ISO-13485, ISO-15189, ISO-17025, ISO-9001, CAP/CLIA, CSV, digital compliance audits, and data integrity. Our team of experts at SPGL RCC excels in identifying areas for improvement, enhancing compliance, and optimizing your operations in accordance with regulations and industry best practices. Through our comprehensive approach and deep understanding of the field, we ensure that your organization maintains the highest standards of quality and regulatory compliance across the entire GxP landscape. SPGL RCC provides a wide range of audits/services tailored to clients' specific needs, including; System Audits: Evaluation and improvement of companies' internal processes and compliance Vendor Audits: Focus on independence and impartiality of vendors systems, priding clients with valuable insights GCP: planned or ongoing clinical studies audits to provide valuable insights relating to compliance, including CRO, investigator sites, TMF, GCLP Computer System Compliance :Ensuring that the computer software used to generate GxP data is in compliance with relevant regulations GLP: including animal studies, toxicological, PK studies, and clinical laboratory specimen testing, to ensure that processes and internal procedures are in compliance with relevant regulations and guidelines Post market surveillance: To evaluate drug and device safety data, compliance with reporting requirements, and adherence to timelines Inspection readiness: including pre-approval inspection, mock inspection, guidance on corrective actions, regulatory inspection training QMS Gap Analysis Data Integrity