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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