President and Founder
Mr. Kulcsar has over 30 years of experience leading a team of accomplished professionals, providing project management, engineering, FDA compliance services, and solving complex manufacturing and regulatory issues. Prior to becoming a full-time executive, Mr. Kulcsar was designing and implementing sophisticated controls and systems automation using PLC, HMI, SCADA and DCS technologies. Industry experience include the life sciences, food and beverage, petrochemical and iron & steel industries.
Vice President of Operations
Mr. Hackl has over 25 years of wide-ranging life sciences experience including engineering, FDA compliance, project management, quality assurance, recruiting, and training. Mr. Hackl works with clients who manufacture in FDA regulated environments, to validate systems, ensure quality, optimize processes, and achieve successful outcomes. Specific process knowledge in the following sectors; oral solid dose, diagnostics, fermentation, purification, aseptic fill, biotech, OTC, and medical device.
Director of Plant Information Systems
Mr. Megyeri has over 30 years of experience implementing information technology and controls engineering solutions that deliver substantial value, generate profit, and secure customer loyalty. He has significant expertise implementing large scale Control Systems, Manufacturing Execution Systems (MES), Historians, Dashboards, custom databases and reporting solutions and their integration with business systems. Industry focus includes life sciences, food & beverage, petrochemical and automotive sectors.
Vice President of Southeast Operations
Mr. Quiles has over 20 years of experience as a life sciences executive focusing on the pharmaceutical, medical devices and biotech industries. Mr. Quiles is well versed in quality, operations and product/process development functions. He is a natural leader that understands the technical and consultancy processes, including owning and driving change in business and people development. He has significant experience in operations, quality systems, quality risk management, project and program management, process development and improvement, new product development, technology transfers and validation.
Senior Vice President of Strategic Alliances
Mr. Rugebregt has over 25 years of successful executive, project management, engineering, FDA compliance and business development experience within FDA regulated pharmaceutical manufacturing environments. His project experiences have included biologics facility expansion, automation, technical transfer and Drug Supply Chain Security Act (serialization). Known for fostering service excellence and building strong relationships with clients and business partners while driving projects to completion and meeting project objectives.
Strategic Account Manager
Mr. Sorensen has 19 years of FDA compliance experience in the pharmaceutical and biotech industries ranging from Active Pharmaceutical Ingredient production to finished product manufacturing. He works with clients to develop FDA compliance solutions in order to meet regulatory requirements. He has specific technical knowledge, including process validation, in the following sectors: API manufacturing, purification, aseptic fill, sterile fill, solid oral dosage, biotech, OTC and cosmetics.
Vice President of Sales and Customer Relations
Ms. Nelson brings 25 years of global business development and consulting experience in the pharmaceutical and healthcare sector. Her strategic planning skills and ability to drive revenue and growth have enabled her success in leadership roles, global sales, marketing management and operational aspects of new business growth. She has a passion for building relationships and delivering client focused service. She possesses both a chemical engineering and quality background, allowing her a unique ability to provide strategic guidance and expertise around FDA compliance initiatives to our clients.