SMART CONSULTING GROUP LLC

Capabilities

Smart Consulting Group is a progressive consulting company that is providing technical, quality compliance and regulatory assistance to the healthcare industry with specific focus on: ?Pharmaceuticals ?Biotechnology ?Biologics ?Medical Devices Services include: * Subject Matter Expert Support for medical product development and licensure, including CBRN products * Development of a Quality Strategy * Building comprehensive Quality Systems together with implementation of integrated Quality System Elements * Experience with global concerns and implementation * Change Management, Investigations, CAPA, OOS, document systems, audits, risk management and GMP information system support. Compliance Remediation Programs for FDA483’s, Warning Letter and Consent Decrees/Application Integrity Policy. Custom courses are available for a variety of topics as well as individual mentoring type coaching, which provides experienced one-on-one training and guidance