Ensuring GMP Compliance Across Your Operations
Auditing serves as a vital pillar within the GxP framework, verifying regulatory compliance throughout product development and commercial operations while maintaining continuous market authorization.
Our Comprehensive Audit Solutions
At Zentrum24, we function as a seamless extension of your quality teams - delivering independent, objective evaluations of both internal processes and vendor systems to drive compliance, reduce risk, and foster quality excellence.
Regulatory Compliance Audits (FDA, EMA, MHRA, and other global standards).
Vendor/Supplier Quality Audits (CMOs, CROs, and critical suppliers).
GxP Process Audits (Manufacturing, Laboratory and Validation).
Pre-Approval Inspection Readiness Assessments
Remediation Support and CAPA Effectiveness Reviews
Why Partner with Zentrum24 for Your Auditing Needs?
Compliance Assurance: Building Confidence in Your Systems and Processes.
Global Network of seasoned auditors with regulatory and industry experience.
Risk-Based Approach that prioritizes critical compliance areas.
Flexible Engagement Models from single audits to comprehensive programs .
Actionable Reportingwith clear roadmaps for improvement.
Our audit services are designed to not only meet current regulatory expectations but to future-proof your operations against evolving compliance requirements. We combine rigorous assessment methodologies with practical, operational insights to deliver audits that truly add value to your organization.
By proactively addressing compliance fundamentals, we help transform regulatory requirements from obstacles into opportunities for operational excellence.
Why It Matters
Verifying that your internal systems - along with those of suppliers and partners - meet all regulatory requirements is a critical prerequisite before initiating any compliance process. At Zentrum24, we help organizations systematically demonstrate adherence to Good Practice (GxP) guidelines, ensuring all operational aspects satisfy rigorous regulatory standards.
Ready for Your Next Audit?
Avoid surprises. Let’s build a proactive audit plan tailored to your operation.
Whether you're facing a critical inspection, qualifying new vendors, or seeking to close compliance gaps, Zentrum24 offers the audit expertise and regulatory insight you need to move forward with confidence. Let’s work together to make compliance your competitive advantage.
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.