Marina obtained her expertise at Innovative R&D Division in TEVA Pharmaceutical Industries LTD. There she served as a clinical and regulatory operations expert of multi-national, multi-center clinical trials.
After leaving Teva, Marina served as a Chief Operating Officer (COO) of Clinical & Regulatory Affairs for several bio-pharmaceutical start-ups. Among her duties was setting and execution of regulatory strategy, pre-IND and IND submissions, selecting and contracting CROs, consultants and Key Opinion Leaders for various clinical indications.
Marina gained substantial experiance in establishing Quality Systems, including SOP drafting towards ``inspection ready`` state, applied vast experience in the clinical and regulatory field into legal practice while working as an attorney for one of the leading Law Firms in the Bio-pharmaceutical and Medical Device fields.
Marina specializes in commercial and contracts law including Clinical Trial Agreements,(CTAs), Master Service Agreements (MSAs), GDPR Agreements, Quality Agreement etc., assuring compliance with major regulatory authorities' guidelines and regulations.
Marina provides Bio-Medical Companies with General Data Protection Regulation (GDPR) training & implementation services.
In addition, in a framework of commercial aspects of bio-pharmaceutical development, Marina is experienced in performing clinical and legal-regulatory due diligence (including Trial Master File reviews) in connection with licensing transactions related to biotechnology, medical devices and pharmaceuticals at all stages of development and in advising regulatory aspects and challenges to be expected for potential targets for clients' investment, by reviewing and assessing the overall development strategy, both in terms of funding, development status and timelines.