Custom Quality and Regulatory Solutions
Robert Di Tullio is an experienced leader in the diagnostics industry. For 48 years, he has held various positions with multiple organizations, with an emphasis on regulatory, quality and clinical affairs management.
Robert has provided companies, large, small and start-up, with the vision, strategy and leadership to promote commercial success while assuring compliance with global regulations in the competitive marketplace.
Services/Experience
As a solutions oriented leader, Robert has consistently achieved positive results for clients.
He specializes in:
-Worldwide corporate regulatory compliance programs
-Business Venture Start-up and Mergers/Acquisitions
-Providing expert analysis of FDA and international regulations
-Public policy and testimony for healthcare issues before federal and state agencies
-More than 100 FDA PMA approvals and 510(K) clearances of medical devices (CDRH & CBER)
-Robust, compliant Clinical Studies
-COVID-19 Diagnostics (molecular, antigen and antibody tests)
-CLIA Waiver, Point-of-Care (POC) and OTC Diagnostics
-Companion Diagnostics
-Design control process development implementation
-Industry Liaison to Clinical Laboratory Improvement Advisory Committee (CLIAC)
-Software validation for FDA submissions
-International Product Registrations (e.g. EU IVD Regulation, Asia, Canada, Latin America)
-FDA Unique Device Identifier (UDI) Compliance
-HIPAA Compliance Training
-Corporate code of ethics establishment and implementation
-Establishment and implementation of Corrective and Preventive Action (CAPA) systems
-Master Process validation plans
-Foreign Corrupt Practices Act (FCPA) Mediation
-Managing post market product surveillance and total product lifecycle process
-Document Control Systems
-New product technology transfer to manufacturing
