Regulatory Compliance


Regulatory Compliance are categorized as follows:

• Annual Product Reviews / Annual Product Reports
• Batch Records Reviews / Revision / Verification for compliance to filings (NDA / ANDA / CMC Section)
• cGMP, GXP Auditing / Compliance / Training
• Change Control Procedures
• Complaint Reports and Investigations / CAPA
• Evaluation/Assessment of Validation status and Validation/Qualification Documents Assessment
• GAP Analysis, Remediation Plans and Implementation
• Internal cGMP and ISO audits
• Pre-approval Inspection Readiness (PAI)
• Quality Systems Compliance Audits: Investigations / CAPA; Change Control, Complaints, SOP's & Quality Policies; Calibration, Preventive Maintenance, Validation, Laboratory Systems, Audits
• Regulatory Compliance Assessments
• Regulatory Consulting
• Regulatory Enforcement Corrective Actions / cGMP Plans to meet 483's, Warning Letters, Consent Decree commitments
• Risk Analysis
• Regulatory Agencies Regulations Compliance Assessments
• Stability Protocols and Stability Programs
• Standard Operating procedures Development and /or translations

DMC Firewall is developed by Dean Marshall Consultancy Ltd