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Products
Complete KYB verification through AROS Compliance OS to unlock pharmaceutical-grade APIs and bulk pricing.
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Services
Our Services
QC Testing
HPLC, GC-MS, FT-IR, Karl Fischer. 18+ analytical tests with COA.
Regulatory Consulting
FDA 21 CFR Part 211, DMF filing, GMP gap analysis, audit prep.
CRO Services
Custom synthesis, method development, and analytical R&D support.
Clinical Trial Management
Biostatistics, SAS programming, pharmacovigilance, and safety monitoring.
End-to-end supply chain compliance platform. KYB verification, document management, and audit trails.
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Scientific Services
Our Services
End-to-end scientific platform for pharmaceutical companies, from analytical testing and custom synthesis to regulatory compliance and biostatistics.
What We Offer
Comprehensive capabilities across the pharmaceutical development lifecycle.
QC Testing
HPLC, GC-MS, FT-IR, dissolution, and 18+ analytical tests with full COA reports. GMP-ready workflows for API and finished dosage testing.
18+ Tests Available
Custom Synthesis
CRO-grade custom synthesis and contract research services. From milligram to multi-kilogram scale with full R&D support and documentation.
CRO Services
Regulatory Support
GMP compliance consulting, FDA submission preparation, DMF filing support, and regulatory strategy for API and drug product dossiers.
GMP & FDA Ready
Biostatistics & SAS
Statistical analysis, clinical trial data management, SAS programming, and CDISC-compliant datasets for regulatory submissions.
CDISC Compliant
R&D Manufacturing
Process development, scale-up, and pilot manufacturing for APIs and intermediates. From bench to batch with full process documentation.
Bench to Batch
Pharmacovigilance
Safety monitoring, adverse event reporting, signal detection, and risk management plans aligned with global pharmacovigilance standards.
Safety & Compliance
Why Abiozen
Trusted by pharmaceutical companies for quality, speed, and regulatory rigor.
GMP-Ready Platform
Every workflow designed for 21 CFR Part 211 and Part 11 compliance from the ground up.
Fast Turnaround
Accelerated timelines for QC testing, synthesis, and regulatory deliverables.
Expert Scientists
PhD-level analytical chemists, regulatory specialists, and biostatisticians on every project.
Full Documentation
Audit-ready COAs, batch records, and regulatory dossiers delivered with every engagement.
Need a Custom Solution?
Our scientific team can tailor any service to your specific requirements. Whether you need a single assay or a full CRO engagement, we are here to help.
Contact Us
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21 CFR Part 11
FDA Registered
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