GMP Consulting and Audits

International Regulatory Compliance & GMP Assessments

SeerPharma International offers expert assistance in the management of regulatory compliance through integrated GMP and GLP compliance upgrades.

We provide expert GMP services to the Drug, Device, Biotechnology, Diagnostic, BPCs, Cosmetic, Food and Veterinary Industries.

We are able to guide clients to approvals from all international regulatory bodies (FDA, EU, MHRA, TGA, HSA, NPCB) in a professional and cost effective manner.

• GMP and company wide compliance upgrades to all international standards (FDA, EU, PIC/S, ISO)
• FDA style audits to CFR Human and Veterinary Drugs, Biologicals, Devices etc
• Expert guidance in the preparation for regulatory and pre approval inspections (PAI) and site audits
• Assessment of current levels of GMP and Compliance to all international standards
• Strategies to raise the level of GMP Compliance
• Facilitation of regulatory licensing audits and company responses

Quality Assurance Programs

• Review of internal audit programs targeting critical process control points (HACCP) and GMP weaknesses
• Design of comprehensive audit programs for GMP/GLP compliance and manufacturing control
• Risk management approach to QA/QC to ensure resources are utilised effectively
• Microbiological and GMP troubleshooting audits
• Establishment of comprehensive QA and manufacturing improvement programs
      - vendor assurance
      - self inspection systems
      - Hazard Analysis (HACCP)
      - review of QA and CI programs
      - assessment of GLP programs