Keren Smulovitz, B.Sc

Quality Project coordinator

Keren Smulovitz is a graduate of Bachelor of Science degree in Biotechnology from Hadassah Collage, Jerusalem, GCP certified and monitoring clinical trials from Haifa University and Rambam Hospital and Certified for internal and external auditor for ISO 13485 and ISO 9001.

Keren has over three years of experience in the field of consulting for pharmaceutical and medical device companies.

Keren has gained her regulatory affairs experience working in BioPlan Ltd. in registration and regulation of medical devices. Her practice includes submissions of new medical devices, renewals and variations to the Ministry of Health, activities related to pharmacovigilance and post-marketing surveillance, review of IFU, labelling and other marketing material for regulatory compliance.

Within her role In Gsap, Keren leads QA and RA projects in the medical device industry. Her projects including: regulatory strategies for the US and European markets for novel medical device startups, Supplier quality management in Philips, Haifa – supplier qualification and auditing per ISO 13485 and ISO 9001, quality system establishment for aseptic pharmacy unit according to the new Israeli regulatory guidelines, quality system implementing for manufacturers of medical cannabis according to the IMC-GMP and preparing them for IMC-GMP inspection and submission of TOFES 1 to the YAKAR.

In addition, within the framework of Gsap as CRO, Keren help establish Gsap clinical department Quality system, participates in management, monitoring (CRA) and writing of clinical trial documents and SOPs and submissions for clinical trials for startup companies. 

During her work in Gsap, Keren participated in Projects of QA and RA in the following Medical device and Pharmaceuticals companies: Philips Haifa, Aliyah Pharmacy, Ivory Graft, Dead Sea, Medimor Tiberias, BOL Pharma Revadim, Department of bone marrow transplantation of Hadassah Medical Center for FACT JACIE inspection.

As clinical trial CRA, Keren participated in projects in the following companies: Fidmi Medical, SciCann, Ivory Graft, Eximore, ApiFix, Zion Pharma.

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