Candioli Pharma srl, Italy.
Natascia Bruni is an experienced regulatory compliance and quality management professional with over two decades of experience in the pharmaceutical and feed supplements industries. Currently, she serves as the Compliance Unit Director, Qualified Person, and QPPV at Acel Pharma srl, where she plays a pivotal role in ensuring regulatory compliance, managing product registrations, and overseeing pharmacovigilance activities. Throughout her career, Natascia has worked across various sectors, including pharmaceutical companies (human and veterinary), focusing on quality assurance, regulatory affairs, and strategic business compliance. She is well-versed in navigating complex regulatory landscapes and has made substantial contributions to corporate governance, legal risk management, and quality audits.
Profile
Scopus
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Education ๐
Natascia Bruni's educational background demonstrates her deep expertise in both scientific and management fields, which has greatly contributed to her successful career in regulatory affairs and quality management. She completed her degree in Chemistry (Nuclear) at the University of Turin from 1991 to 1996, earning the highest distinction with a final vote of 110/110 con lode. This solid foundation in chemistry equipped her with a thorough understanding of chemical processes and analytical methods, which would later be pivotal in her regulatory and quality assurance roles in the pharmaceutical industry.
In addition to her scientific education, Natascia pursued specialized training in Regulatory Affairs and Pharmacovigilance for Drugs between 2001 and 2002, sharpening her skills in the complex regulatory frameworks governing drug safety and compliance. This training became essential in her role as a Qualified Person and QPPV in various pharmaceutical companies, where she led efforts to ensure products met both safety and regulatory standards.
Furthermore, Natascia completed a Business Management Course from 2015 to 2018, which enhanced her leadership, strategic planning, and operational management abilities. This course helped her integrate business and regulatory perspectives, allowing her to lead teams and drive organizational success in compliance-related activities.
Natascia also deepened her technical expertise by attending the School in Technology Enhanced Chemical Synthesis from 1996 to 1999, where she learned advanced techniques in chemical synthesis that continue to inform her work in pharmaceutical and feed supplement regulatory processes. Her multi-disciplinary education has provided a strong foundation for her leadership role in compliance and regulatory affairs, combining scientific rigor with strategic management skills.
Experience ๐ผ
Compliance Unit Director - Qualified Person - QPPV (2012โPresent), Acel Pharma srl (Candioli Group), Beinasco (Torino)
Responsible for ensuring the regulatory compliance of raw materials and finished products, overseeing registration/approvals, and managing import/export activities. Works closely with various departments to ensure that all products sold comply with national and international regulations.
Quality Unit Manager & Qualified Person (2007โ2012), Olon Spa (Fidia Group), Rodano (MI) and Settimo Torinese (To)
Led the harmonization of QA/QC and regulatory procedures across two sites, ensuring GMP and regulatory compliance for the companyโs product portfolio. Managed communications with health authorities and conducted quality audits for suppliers.
Chemistry Department Responsible (1997โ1999), Antibiotic Spa, Settimo Torinese (To)
Conducted independent research and developed experimental procedures within the research project scope.
Researcher (1996โ1997), Antibiotic Spa, Settimo Torinese (To)
Developed analytical methods and processes in the field of pharmaceutical research.
Research Interests ๐ฌ
Regulatory Compliance in Pharmaceutical Products ๐
Natascia is particularly interested in the regulatory compliance of both raw materials and finished products in the pharmaceutical industry. Her work emphasizes the critical importance of navigating complex regulatory frameworks and ensuring that all pharmaceutical products, especially those used in veterinary medicine, comply with the highest standards of food safety, quality control, and marketing.
Pharmacovigilance & Product Registration ๐
A key area of Natascia's research is in pharmacovigilance, particularly focusing on the monitoring and reporting of adverse effects for drugs, ensuring products maintain safety and compliance throughout their lifecycle. She explores the processes involved in product registration, striving to streamline the approvals and regulatory checks necessary for market entry, particularly in international markets.
Process Improvement Methodologies ๐ง
Natascia is also keen on exploring process improvement methodologies within the regulatory compliance space. Her work in this area aims to enhance operational efficiency, reduce legal risks, and strengthen internal control structures. By continuously improving regulatory and operational processes, she contributes to creating a safer and more efficient regulatory environment for pharmaceutical companies, particularly in the feed supplement and veterinary drug sectors.
Awards ๐
University Senate Award: Best Academic Graduate (1996)
Awarded for excellence in academic performance by the Presidency Council of the Italian Chamber.
OPTIME Award: Best Experimental Dissertation of the Year (1996)
Recognized by the Industrial Union for outstanding research work.
Publications ๐
"Molecular Characterization of the Gorgonzola Cheese Mycobiota and Selection of a Putative Probiotic Saccharomyces cerevisiae var. boulardii for Evaluation as a Veterinary Feed Additive" Published in Applied Microbiology, 2024, 4(2), pp. 650โ664.
"Efficacy of a Dietary Supplement in Dogs with Osteoarthritis: A Randomized Placebo-Controlled, Double-Blind Clinical Trial"
Published in PLoS ONE, 2022, 17(2), e0263971.
"Chronic Kidney Disease and Dietary Supplementation: Effects on Inflammation and Oxidative Stress", Published in Veterinary Sciences, 2021, 8(11), 277.
"Chronic Intestinal Disorders in Humans and Pets: Current Management and the Potential of Nutraceutical Antioxidants as Alternatives", Published in Animals, 2022, 12(7), 812.