Regulatory Consulting

LIST OF CONSULTING SERVICES:

FDA’s QSR/GMPs – 21 CFR Parts 820, 210 & 211, 600, 806, 58, 7, and 11, 803, 806, QSIT Mock Inspections Root Cause Analysis and CAPA Post-Market Surveillance and Vigilance ISO 13885, 9001:2015, 14971 MDD/IMDD requirements MHLW Ministerial Ordinance no. 169 Health Canada Medical Device Regulations Quality Engineering Design Control Design Dossier Reviews Technical Files Compilation ERES and Documentation Systems Complaint Handling HIPAA requirements Process Validation CE-Marking Post Market surveillance and Vigilance programs Quality Systems and Systems-based Implementation & Auditing Process Validation Supplier Quality Agreements Quality Engineering Mock FDA inspections Risk Management / hazard analysis Process Improvement Lean Manufacturing and Six-sigma

Compliance Master Plan remediation Facilitating responses to address FDA-483s and Warning Letters Product Registrations Pre-Approval and Readiness Assessments CAPA remediation Complaint Handling and MDR remediation Pharmaceutical, and Biologics Industries Facilitating responses to address FDA-483s and Warning Letters ERES and Documentation Systems Quality Assurance and Audits Quality Systems and Systems-based Implementation & Auditing OTC Cosmetics Aseptic audits & Aseptic operations Cleaning Validation Regulatory Compliance Failure Investigation and OOS Deviation Handling Equipment qualification Documentation Systems cGMPs, GCP, GLP Training Supplier Quality Assurance Analytical method validation Change control programs sterility assurance Pharmacy Compounding Audits USP 797 GLP Laboratory