SERVICES
Quality Assurance
PTSI delivers comprehensive Quality Assurance solutions designed to support clinical and commercial biopharmaceutical manufacturing. Our QA experts bring real-world experience as former client-side leaders and regulatory professionals, ensuring quality systems are practical, scalable, and aligned with global regulatory expectations.
We build and strengthen quality frameworks that support operational excellence, regulatory confidence, and long-term compliance.
Quality System Design & Implementation
We develop and remediate phase-appropriate Quality Management Systems (QMS) that align with FDA, EU, and global GMP requirements.
Capabilities include:
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QMS architecture and governance framework development
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SOP authoring, review, and harmonization
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Document control systems and lifecycle management
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Data integrity program development
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Quality policy and quality manual development
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Risk management integration (ICH Q9 principles)
Our approach ensures systems are both compliant and operationally sustainable.
Deviation, CAPA & Investigation Management
We establish structured, risk-based processes that drive root causes understanding and sustainable corrective actions.
Services include:
• Deviation and nonconformance program design
• Root cause analysis facilitation
• CAPA development and effectiveness verification
• Investigation writing and remediation strategy
• Trend analysis and quality metrics reporting
We move organizations from reactive correction to proactive quality management.
Audit & Inspection Readiness
PTSI prepares organizations for regulatory engagement with confidence.
Support includes:
• Internal audit program development and execution
• Mock FDA / EMA inspections
• Pre-Approval Inspection (PAI) readiness
• Supplier audit programs
• Remediation planning and execution
We focus on closing gaps before inspectors find them.
Supplier Quality & Oversight
We implement risk-based supplier qualifications and oversight programs to protect product quality and supply continuity.
Capabilities include:
• Supplier risk assessments and categorization
• Quality Agreement development and negotiation support
• Supplier audit execution and reporting
• Ongoing performance monitoring and scorecards
Training & Quality Culture
A strong quality system requires a strong quality culture.
We support:
• GMP and GDP training programs
• Role-based quality training
• Train-the-trainer programs
• Quality culture transformation initiatives
PTSI establishes Quality Assurance as a strategic asset enabling compliance, operational efficiency, and scalable growth