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Analytical Testing

Precision Analytics
Global Compliance

At Abiozen, we redefine pharmaceutical quality assurance with industry-leading analytical testing services engineered for every stage of the product lifecycle—from R&D to commercial distribution. Leveraging state-of-the-art laboratories, expert scientists, and global regulatory alignment (ICH, USFDA, EMA, USP, EP, JP), our testing solutions ensure the highest standards of safety, efficacy, and compliance. Whether you’re navigating early formulation or preparing for global market entry, Abiozen is your strategic partner for accelerated, audit-ready outcomes.

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Comprehensive Quality Testing

Advanced analytical solutions to safeguard pharmaceutical integrity from lab to launch

Method Development and Validation

Abiozen develops and validates robust analytical methods to ensure the accuracy, precision, and reliability of pharmaceutical testing. Our team designs custom assays tailored to each product’s profile, using technologies such as HPLC, GC, and MS. Adhering strictly to ICH Q2 guidelines, we evaluate all critical parameters to ensure regulatory readiness. We also offer seamless method transfer support to facilitate global scalability across labs and manufacturing sites. Our process-driven framework minimizes variability while maintaining analytical integrity.

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Stability Studies

Our stability testing services help define the shelf-life and storage conditions of pharmaceutical products through long-term and accelerated studies. Conducted under ICH-recommended environmental conditions, we simulate real-world and stress scenarios to assess degradation and ensure quality over time. We also conduct photostability and forced degradation studies to uncover potential risks. Data generated is designed for global regulatory compliance and product reliability. Abiozen’s approach ensures your product’s stability and safety throughout its lifecycle.

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Contamination Control and Microbial Testing

Ensuring sterility and microbial safety is critical, especially for injectable and high-risk formulations. Abiozen’s contamination control services include endotoxin detection via LAL tests, sterility testing in ISO Class 5 environments, and particulate analysis in compliance with USP and EP standards. We use MALDI-TOF and PCR for rapid microbial identification and offer comprehensive environmental monitoring. These protocols mitigate contamination risk and maintain GMP-compliant manufacturing conditions, aligning with global quality expectations.

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Batch Release Testing

Our batch release testing services ensure that each pharmaceutical batch meets stringent quality and regulatory specifications before market distribution. We perform full-spectrum testing, including identity, purity, potency, and safety evaluations on raw materials and finished products. All testing complies with USP, EP, and JP standards, supporting seamless market access worldwide. With a focus on efficiency and accuracy, Abiozen enables faster product release without compromising on compliance. Our infrastructure supports high-throughput operations with reliable turnaround times.

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Residual Solvents and Heavy Metals Analysis

Abiozen ensures the safety of pharmaceutical products through precise detection of residual solvents and heavy metals. We use GC-FID and headspace analysis for quantifying Class 1–3 solvents per ICH Q3C guidance, and ICP-MS for trace-level heavy metal detection in line with USP <232> and ICH Q3D standards. These services protect patients from toxic exposure and support global regulatory submissions. Our instrumentation offers high sensitivity and specificity, ensuring risk-free and compliant formulations.

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Expertise across the entire drug development lifecycle

IND Enabling Services

Accelerate regulatory filings with expert IND strategies that ensure speed without compromising quality.

Analytical Testing

Comprehensive analytical support delivering purity, potency, and regulatory-ready data.

Process Development

Resolve early-stage challenges with scalable, validation-ready process design.

Clinical Trial Material Production

GMP-compliant CTM manufacturing with full aseptic processing and flexible batch sizes.

Clinical Supply & Logistics

Global distribution with real-time tracking and packaging tailored to trial protocols.

Trial Management & Biostatistics

Adaptive trial execution with real-time data and regulatory-grade statistical insights.

Commercial Scale Manufacturing

Seamless scale-up to high-volume production with automated sterile filling lines.

Technology Transfer

Validated, risk-mitigated process transfer ensuring global compliance and consistency.

Packaging & Serialization

End-to-end packaging with global serialization and multilingual compliance solutions.

Generic API Manufacturing

High-quality, scalable API production with regulatory-aligned synthesis protocols.

Intermediates and RSMs

Reliable supply of key intermediates and starting materials with global reach and control.

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Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

Seamless Analytical Method Transfers for Global Scalability

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

ICH Q2-Compliant Method Validation for Regulatory Excellence

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

Precision-Driven Custom Assay Development for Critical Quality Attributes

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

Seamless Analytical Method Transfers for Global Scalability

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

ICH Q2-Compliant Method Validation for Regulatory Excellence

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Analytical Testing

Seamless Analytical Method Transfers for Global Scalability

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

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