Plamena Entcheva Dimitrov

A highly accomplished regulatory, clinical, and quality affairs executive with extensive experience supporting medical device, pharmaceutical, biotech, and combination product companies, she is the founder of Preferred Regulatory Consulting and Preferred Clinical Research, organizations dedicated to accelerating medical innovation from concept through commercialization. Her expertise spans global regulatory strategy, clinical development, quality systems management, and regulatory submissions across the United States, Europe, Canada, and other international markets.

Over the course of her career, she has guided companies through complex regulatory pathways involving FDA, MHRA, Health Canada, Notified Bodies, IRBs, and other global agencies. Her work includes leadership in INDs, PMAs, IDEs, 510(k)s, de novos, technical files, clinical trials, quality management systems, and compliance programs for a wide range of products, including digital health technologies, implantable devices, biologics, gene therapies, and catheter-based systems.

Known for her strategic leadership and hands-on execution, she has served as a trusted advisor and fractional executive for numerous startup and growth-stage life sciences companies, helping organizations navigate regulatory complexity while reducing development risk and accelerating commercialization timelines. Her therapeutic expertise spans cardiovascular, pulmonary, neurology, nephrology, gastroenterology, orthopedics, rare diseases, and women’s health.

In addition to her consulting and executive leadership work, she is passionate about innovation, entrepreneurship, and holistic wellness, reflected through her work as creator of Essential Teas, a handcrafted herbal tea brand focused on health and well-being.