Abiozen’s analytical laboratories deliver end-to-end testing and validation services to ensure every pharmaceutical product meets the highest standards of quality, safety, and regulatory compliance. Supporting all stages of the product lifecycle—from formulation and scale-up to commercial batch release—our labs are equipped with the latest technologies and governed by stringent quality systems aligned with global health authorities.

Method Development and Validation
Our analytical scientists develop and rigorously validate methods using advanced techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV/Vis spectroscopy, and dissolution testing. All methods are designed and validated according to ICH Q2 guidelines to ensure accuracy, precision, specificity, linearity, and robustness, supporting both regulatory filings and internal quality benchmarks.

Batch Release Testing
Every production batch undergoes comprehensive testing before market release. Our protocols include identity verification, potency quantification, impurity profiling, and microbiological testing. These assessments ensure that each batch complies with its regulatory specifications, meets therapeutic standards, and maintains safety for end-users.

ICH-Compliant Stability Studies
We conduct a full suite of stability studies under real-time, accelerated, and stress conditions to evaluate product shelf life, degradation profiles, and recommended storage conditions. These studies provide critical data for regulatory submissions, packaging decisions, and long-term quality assurance, helping clients maintain consistent performance throughout a product’s commercial lifecycle.

Contamination Control and Microbiological Safety
Our facilities feature environmental monitoring systems and validated cleanroom practices to uphold contamination-free operations. We perform endotoxin testing, sterility testing, bioburden analysis, and particulate matter assessments for sterile and non-sterile products. These controls ensure that products meet global safety standards and are suitable for critical therapeutic use.

Regulatory Readiness and Documentation
All analytical testing is supported by detailed documentation, including method SOPs, validation reports, and stability protocols suitable for submission to regulatory authorities such as the FDA, EMA, and WHO. This structured and compliant approach ensures that our clients are audit-ready and equipped for successful product approvals in all target markets.