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Gsap – led by Dr. Sigalit Ariely-Portnoy - provides best in class value-added services to medical device, pharmaceutical, biotechnology, cell therapy and immunotherapy companies. Our services include risk assessments, gap analyses and on-site auditing; establishment and improvement of quality systems (e.g. GMP, GLP, ISO); validation of processes, equipment and facilities; regulatory strategy development including submission to the regulatory authorities (e.g. Israel MOH, FDA); clinical trial services (i.e. set-up, management, monitoring, documents review, auditing). Our team of >50 experts has an unparalleled cumulative extensive experience in leading successful complex projects requiring interdisciplinary cooperation while creating an integrative impact."