Smart Consulting Group, LLC

Smart Consulting Group provides technical and regulatory compliance support for biotechnology, medical devices, pharmaceuticals, vaccines, and specialty products, solving complex challenges for both the industry and governments. We provide advisory and support services in a broad range of categories, including but not limited to: • FDA Regulatory Compliance • Quality Systems Design and Implementation • Forensic Analysis for Data Integrity • GMP, GLP, and GCP Audits • Assessments and benchmarking • Compliance and Quality Risk Assessment • Regulatory Strategy • Product/Process Development/Manufacturing • Laboratory Compliance and Operations Analysis • Documentation Management Support • Project Management • Technology Transfer Strategy and Oversight • Staffing support for highly specialized talent • Support services to facilitate organizational change Smart Consulting Group has expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue-engineered products, and device-combo products.