Professional summary

Plamena Entcheva-Dimitrov is a regulatory, clinical and quality management consultant, specializing in the areas of combination products, drug delivery catheters, implantable devices and imbedded and standalone software.
Plamena is also the founder of an Eastern Europe oriented US-based CRO focused on accelerating medical innovation and commercialization of medical products to the global markets by reducing clinical study time and cost. Her efforts have allowed patient access to novel technologies and have brought innovative products to the market, expanding and solidifying clients' portfolios in the areas of cardiovascular, pulmonology, urology, gynecology, nephrology, ENT, ophthalmology, orthopedics, neurology, and metabolic diseases. Plamena’s

Engagement overview

Assisting clients with 510(k), de novo and PMA marketing submissions and investigational submissions to FDA and IRB/ECs; working with regulators on behalf of our clients to resolve submission issues and obtain clearance or approval on the US and EU market. Quality and compliance assistance, audit preparation and representation. Clinical studies protocols and reports.


• Small to mid size medical device and pharma companies
• Catheter-based technologies
• Drug delivery
• Combination products
• Stand-alone
• Imbedded software.