Specialty service provider for quality assurance and regulatory compliance functions in Medical Device industry and Clinical operations in Life science industry, ISO Certifications ISO 9001, ISO 13485, MDSAP, QSR, 21 CFR Part 820, TGA, HC, SOR-98/282, JPAL, MHLW, Ord. 169, ANVISA RDC, Mock regulatory audits, product technical reviews, Quality auditing, Pharmaceutical Quality Systems, ICH-GCP, Trial Data management, Project management.
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