Summary

FDA Regulatory Affairs, FDA compliance, Biotechnology Products, Vaccines, Expert Witness, Quality Systems, FDA Consent Decree, Pharmaceuticals, Manufacturing, Medical Product Development, Medical Device regulation, Analysis of Alternatives, Medical Product Manufacturing, Biosafety, Pharmaceutical Investigations and CAPA

Description

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

Profile

  • Incorporated in
    Pennsylvania
  • Established since
    1999
  • Main/Branch
    Branch

Address

Contact