Accelerating Biopharmaceutical Innovation from Pipeline to Patients
At Zentrum24, we recognize the vital importance of bringing transformative therapies to market efficiently while maintaining uncompromised quality.
Comprehensive CMC Regulatory Solutions
At Zentrum24, we recognize the vital importance of bringing transformative therapies to market efficiently while maintaining uncompromised quality.
Our biopharmaceutical specialists combine deep therapeutic expertise with flexible, tailored approaches to optimize every stage of your development journey.
Our CMC Services
Our Chemistry, Manufacturing & Controls (CMC) team delivers end-to-end global regulatory support
Strategic CMC Services
-Regulatory Strategy Development: Region-specific roadmap creation for optimal approval pathways.
- Scientific & Technical Writing: Precision-crafted documentation for all submission types.
-Lifecycle Management: Expert handling of variations, amendments, and supplements
Full-Development Support
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Early-phase development planning.
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Marketing authorization application preparation .
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Post-approval maintenance and compliance.
Technical Expertise
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Dossier structure optimization
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Specification development
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Analytical method validation
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API and drug product regulatory alignment
Comprehensive Service Portfolio
Zentrum24’s team of seasoned Biopharma Regulatory Experts delivers integrated, science-driven CMC support across your product’s lifecycle.
Strategic Regulatory Support
Development of strategies tailored to regional requirements (US, EU, Japan, Canada, Emerging Markets). Health authority interaction, planning and meeting support (pre-IND, scientific advice, post-submission). Gap analysis and regulatory due diligence assessments
Regulatory Documentation
High-impact technical writing for all submission types.
Complete dossier preparation and review.
Response letter strategy and authoring.
Operational Excellence
Dedicated biopharma project management.Cross-functional troubleshooting and investigations. Training sessions and strategy workshops (remote or in-person)
Why Partner With Us
We transform CMC challenges into strategic advantages, ensuring your therapies progress efficiently while meeting evolving health authority expectations worldwide.
Global Regulatory Mastery
Expertise across FDA, EMA, and international frameworks
End-to-End Perspective
Seamless support from preclinical through commercialization
Therapeutic Breadth
Experience across all medicinal product categories
Operational Alignment
Solutions synchronized with your manufacturing and quality systems
Ready to Strengthen Your Quality System?
Link build a culture of compliance, confidence, and continuous improvement. Whether you're working at one facility, people will be regularly responsive, or significantly put forward separate training sessions as appropriate when the process is continuous and sustainable.
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.