Pharmaceutical Consulting Services

STAT-A-MATRIX provides the training, evaluation, planning, and consulting your organization needs to comply with FDA’s CGMPs and PAT initiatives, and to implement lean and Six Sigma tools.

The STAT-A-MATRIX (SAM) 14-step implementation process is easily adaptable to companies seeking compliance with CGMPs for finished pharmaceuticals. In addition, SAM can provide customized consulting services for FDA-regulated organizations seeking assistance with design control, process validation, risk assessment and analysis, PAT and Six Sigma tools, pharmaceutical GMPs, good laboratory practices (GLPs), and responses to FDA findings.

Our seasoned industry experts, including former FDA investigators, have worked with major medical device and international pharmaceutical companies all over the world in such areas as:

FDA Compliance

• Regulatory strategy development
• Guidance on CGMP compliance for finished pharmaceuticals
• Guidance on establishing and implementing the PAT initiatives
• On-site audits

ISO 9001 Compliance

Crisis Intervention

• FDA inspectional observations (Form 483)
• Warning letters
• Product recalls

International Compliance

• ICH Q9 Quality Risk Management
• ICH Q10 Draft Pharmaceutical Quality Management System