GMP Expertise for Regulatory Success
Pharmaceutical & Life Sciences Consulting
Zentrum24 delivers specialized consulting services for pharmaceutical, biotech, and life science companies. We help you navigate regulatory complexities with confidence and precision with AI agents.
Stay Compliant, Stay Competitive
Our consultants bring decades of hands-on experience in pharmaceutical manufacturing, regulatory audits, and GMP implementation across global markets.
Partner with Experts Who Know the Science
Whether you're launching a new product or upgrading an existing facility, we offer insight-driven strategies that keep your operations compliant, validated, and inspection-ready.
Don’t risk delays or penalties—let our team ensure you're aligned with FDA, EMA, and WHO standards from start to finish.
GMP-Certified Expertise
30+ Years in Pharma
Fast & Compliant Solutions
Trusted by Industry Leaders
OUR CORE SERVICES
Supporting Every Stage of Pharmaceutical Development
1
Regulatory Writing
Our Chemistry, Manufacturing, and Controls (CMC) team offers comprehensive regulatory strategy guidance, scientific and technical writing support, and global management of quality variations, amendments, and supplement submissions. We provide end-to-end CMC regulatory expertise, spanning early-stage development through the preparation and submission of marketing authorization application dossiers, as well as post-approval support.
2
Commissioning, Qualification and Validation
Our experienced CQV professionals possess extensive expertise across the entire Validation Lifecycle (VLC), with a proven track record supporting clients in all major sectors of the Life Sciences industry. We assist clients in selecting the optimal CQV strategy and provide end-to-end support for all deliverables—including protocol development, on-the-floor execution, data analysis, and final report preparation
CQV
3
Auditing for GxP Compliance
Our team of technical experts collaborates closely with clients to deliver strategic and tactical guidance, ensuring compliance with regulatory obligations. Zentrum24 is a pioneer in Virtual Audits, establishing itself as an industry leader through the successful execution of both routine and highly complex mock Pre-Approval Inspections (PAIs) using innovative virtual methodologies.
Audit for GxP compliance
4
GMP Technical Consulting
Our cross-functional MS&T/QC/QA/Validation, supply chain experts provides comprehensive quality support, including quality assurance review of controlled documents, technology transfer of analytical methods and process compliance, laboratory investigations (including QC microbiology), cleaning validation, chemistry and instrumentation support, and external manufacturing services—ensuring robust quality systems and regulatory compliance across all operational stages.
GMP Technical consulting
5
Quality Systems and Compliance
Zentrum24 offers comprehensive support for Pharmaceutical Quality System (PQS) planning, development, and implementation. Our expertise extends to remediating non-compliant or ineffective PQS, as well as providing targeted assistance for specific PQS elements, including but not limited to: - Supplier Management - Quality Risk Management (QRM) - Change Management - Learning Management - Deviation Management
Quality System and Compliance
FAQ
Answers to help you understand how Zentrum24 supports your compliance journey.
