PROVIDING A SINGLE SOURCE OF TRUTHNavitas Life Sciences is a full-service, technology-driven Clinical Research Organization (CRO) with operations across the globe. They specialize in Clinical Trials, Regulatory Affairs, and Pharmacovigilance across the complete product lifecycle, supporting innovator and generic biopharma companies to bring their products to market quickly and effectively. "Our clients are looking for a partner to support them in increasing operational efficiencies and reducing costs, while ensuring high quality, regulatory compliant, outputs," says Marty Boom, Global Head Regulatory & Safety, Navitas Life Sciences. "Our clients range from top global pharma majors, to biotech organizations, to smaller companies with just one or two products in the market. We are proud to work with US Federal government institutions like the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Center for Disease Control (CDC), to name a few." Navitas Life Sciences is a well-established technology partner for the life sciences industry, providing technologies that drive successful outcomes and provide a single source of truth. They provide application infrastructure for regulatory, content management, quality, track and trace, serialization, and business intelligence. Global standards are adopted and institutionalized across all services covering ISO, GAMP5, GxP, and 21-CFR Part 11 compliance needs. These alignments ensure that the product or services offered are in line with the statutory requirements of all regulatory bodies. Our regulatory technologies are: · Intuitively operated platforms· The most economical for regulatory submissions in the industry and enable faster product approvals and commercialization· Fully integrated, compliant, web-based platforms to create and manage your global regulatory submissions either on premise or cloud based.Our regulatory technologies empower core advantages:· Standardize - achieve global and local regulatory compliance· Optimize - provide streamlined holistic processes· Align - global cross-functional alignment with internal & external business roles· Accelerate - shortening the overall timeline for submission· Save cost - cloud based or on-premise economical solutions for small, medium & large pharmaNavitas Life Sciences built the next-generation mobility platform, traceREADY, as a device-independent application Marty Boom, Global Head Regulatory & Safety, Navitas Life SciencesC O V E R S T O R Y
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