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Nicoleta Spînu


Throughout my initial studies in Pharmaceutical Sciences, I developed a passion for regulatory affairs. I followed several internships and programmes that enabled me to gain practical experience. I even chose to write my Master's thesis on a topic related to pharmaceutical legislation.

However, I was always in between research and regulatory affairs. Science is a place that allows me to be creative and that subsequently led me towards developing an interest in computational modelling. Legislation and policy decision-making taught me to be pragmatic and think strategically about a problem.

Both made me understand why it is challenging for the regulatory authorities to keep pace with the innovation. On the other hand, bridging the gap between the early-stage start-ups and the market should not be a coin toss opportunity. An AI solution is mainly about data, models and computational infrastructure. With a tailored regulatory strategy, any start-up should be able to comply with the regulatory requirements and be an added-value to the healthcare system. That’s one of the million reasons for joining OpenRegulatory along with the shared vision and values, to help others that can improve and have a positive impact on a patient’s life.

My role herein covers helping with medical writing as well as the FDA certification but not limited to.

See you around! :)

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