-Worldwide corporate regulatory compliance programs
-Business Venture Start-up and Mergers/Acquisitions
-Providing expert analysis of FDA and international regulations
-Healthcare Industry Public Policy
-More than 100 FDA PMA approvals and 510(K) clearances of medical devices (CDRH & CBER)
-Robust, compliant Clinical Studies
-Infectious Disease Diagnostics (molecular, antigen and antibody tests)
-CLIA Waiver, Point-of-Care (POC) and OTC Diagnostics
-Companion Diagnostics
-Design control process development implementation
-Medical Device Software Validation Compliance for FDA submissions
-International Product Registrations (e.g. EU IVD Regulation, Asia, Canada, Latin America)
-FDA Unique Device Identifier (UDI) Compliance
-HIPAA Compliance Training
-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