Quality Systems That Withstand Inspection
We provide end-to-end solutions for Pharmaceutical Quality Systems, from initial design through implementation and remediation.
Core Services & Targeted Support Areas
Complete PQS Development & Implementation - Building compliant systems tailored to your operations.
PQS Remediation - Optimizing underperforming systems to enhance compliance and efficiency.
Regulatory-Aligned Frameworks - Designing systems meeting MIA (Manufacturing and Importation Authorisation) and WHO requirements.
Supplier Quality Management.
Quality Risk Management (QRM).
Change Control Management.
Training/Learning Management Systems.
Deviation/CAPA Management.
Our experts deliver customized solutions that balance regulatory compliance with operational practicality, ensuring your quality systems drive both compliance and business performance.Quality Management System (QMS): The Foundation of Life Sciences Excellence.A robust Quality Management System (QMS) – or Pharmaceutical Quality System (PQS) as defined by ICH Q10 – serves as the structural backbone of every successful life sciences organization. This formalized framework establishes the processes, procedures, and accountability required to achieve both quality objectives and regulatory compliance.
What We Offer
GMP Gap Assessments
We evaluate your current quality system against global GMP standards and provide practical, prioritized recommendations.
QMS Design & Implementation
From SOPs and change control to deviation management and CAPA systems, we build tailored QMS frameworks that support your operations.
Inspection Readiness Support
We help your team prepare for regulatory audits by conducting internal reviews and training on documentation, risk management, and best practices.
Continuous Improvement Planning
We don’t just build systems — we help you maintain and improve them over time with metrics, reviews, and training
Key Principles of an Effective QMS/PQS
Phase-Appropriate Design: Tailored to your development stage (early/late clinical or commercial) and operational model (in-house or virtual/outsourced). Regulatory Alignment: Compliant with ICH Q10 and global standards while maintaining operational flexibility. Integrated Architecture: Interdependent elements working synergistically to ensure consistent product quality. Operational Efficiency: Balanced documentation to prevent bureaucracy while maintaining compliance.
Our Comprehensive Service Offerings
Zentrum24 delivers customized quality and compliance support, ranging from targeted QMS enhancements to full outsourcing of your Quality function—including external manufacturing and supply chain oversight.
1. CMO & Supplier Management
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Design and implementation of Contract Manufacturing Organization (CMO) onboarding processes.
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- Vendor/supplier qualification and ongoing performance monitoring.
2. Quality Staff Augmentation
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Deployment of Qualified Persons (QP), Responsible Persons (RP), and QA Subject Matter Experts.
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- Flexible staffing solutions for operational QA personnel (short- or long-term).
3. Compliance & Quality Issue
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End-to-end management of complaints, recalls, and product quality defects.
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- GxP audits and mock regulatory inspections (aligned with FDA, EMA, and other global standards) .
4. Virtual QMS Implementation
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Customized remote quality systems for distributed operations.
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Complete outsourcing of Quality functions for lean organizations.
Ready to Strengthen Your Quality System?
Let’s build a culture of compliance, confidence, and continuous improvement.
Whether you're launching a new facility, preparing for a regulatory inspection, or upgrading your current systems—Zentrum24 is here to support you with proven expertise and tailored solutions that meet global GMP standards.
Why Choose Us
Parenteral Specialization
Focused expertise in complex modalities (mAbs, vaccines, cell therapies, LNP )
Science-Driven Compliance
Technically-grounded strategies that preempt regulatory challenges.
Global Regulatory Mastery
Proven navigation of FDA, EMA, and 30+ international frameworks.
Therapeutic Breadth
Successful delivery across all medicinal product categories.
End-to-End Solutions
Seamless support from discovery through post-approval commercialization.
Operational Synchronization
GMP-aligned solutions integrated with your quality systems.