Alcoax Laboratories Sdn. Bhd. – Empowering Pharma with Quality & Compliance.

Shaping the Future of Pharmaceutical Testing

Alcoax Laboratories Sdn. Bhd. is a Malaysia-based ISO/IEC 17025 and NPRA-accredited pharmaceutical testing lab. We specialize in high-precision analytical testing, regulatory consulting, and strategic sourcing to support product development and market access.

Quality Driven Analytical Testing

Backed by a team with deep expertise in regulated pharmaceutical environments and fully cGLP-compliant systems, we deliver testing and research solutions that prioritize quality and compliance at every step.

Beyond Testing: Pharmaceutical Expertise That Delivers Reliable Results

At Alcoax, we go beyond testing to offer complete, science-driven solutions. With deep pharmaceutical & regulatory expertise, we support every stage; from R&D to commercialization. Problem-solving is at our core.

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Our Mission

To deliver accurate, reliable, and globally compliant pharmaceutical testing and regulatory solutions that enable our clients to bring safe, high-quality products to market efficiently.

Our Vision

To be a leading pharmaceutical testing and consulting partner in Asia, recognized for our scientific excellence, regulatory expertise, and commitment to improving global healthcare standards.

Our Services

Our Comprehensive Solutions

From analytical testing and formulation development to dossier registration and strategic sourcing, Alcoax delivers end-to-end services to support product quality, regulatory approval, and market success.

In-house Testing

As a fully equipped pharmaceutical lab, Alcoax acts as an extension of your QC or analytical testing team, your trusted partner for all routine testing needs.

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Collaborative Testing

Combining deep hands-on expertise with the right partnership, we deliver advanced testing solutions and world-class research, right within your reach and comfort.

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Standards

The reliability of results, whether for impurities or active ingredients, greatly depends on the right quality standards. We supply high-quality standards, backed by supporting data, at competitive prices that optimize both quality and cost.

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Control Nitrosamines (NDSRIs)

Not just testing and reporting, we deliver comprehensive solutions for risk assessment and strategic impurity control to ensure your product complies with global nitrosamine impurity regulations.

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Succeeding Bioequivalence

Succeeding in bioequivalence isn’t a matter of luck—it requires sound scientific approaches. By leveraging advanced in vitro, in silico, and in vivo methods, we help you make the best-informed decisions.

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Polymorphism Studies

Polymorphic changes may significantly impact in-vitro dissolution and bioequivalence. Ensure your product is thoroughly assessed by global expert.

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Why Choose Us

Delivering Compliance & Innovation.

At Alcoax, we don’t just provide testing; we deliver complete solutions that empower your decision-making and drive you forward with confidence and excellence.

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Regulatory Expertise

Deeply aligned with global regulatory standards, we ensure your solutions meet compliance every step of the way.

End-to-End Support

From concept to successful execution, we deliver complete solutions that accelerate your product development and ensure uncompromising quality.

Global Network, Local Insight

We offer world-class solutions from the heart of Malaysia, delivering excellence with a global reach.

Why Choose Us

Delivering Compliance & Innovation.

At Alcoax, we don’t just provide testing; we deliver complete solutions that empower your decision-making and drive you forward with confidence and excellence.

Get In Touch

Regulatory Expertise

Deeply aligned with global regulatory standards, we ensure your solutions meet compliance every step of the way.

End-to-End Support

From concept to successful execution, we deliver complete solutions that accelerate your product development and ensure uncompromising quality.

Global Network, Local Insight

We offer world-class solutions from the heart of Malaysia, delivering excellence with a global reach.

Our Achievements

Proven Expertise in Numbers

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Years Of Combined Team Experience

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Successful Product Developments.

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Product Method Validations

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High-Quality Sample Testing

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Trusted Satisfied Clients

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Citations Of Team’s Publications

FAQ’s

Common Questions About Our Services

Have questions about our services or processes? Explore answers to common queries regarding testing, sourcing, and regulatory support at Alcoax Laboratories.

What products do you test?

We provide a wide range of pharmaceutical and nutraceutical testing services. Please refer to our Analytical Services page for more information.

What certifications/accreditations does your lab have?

Alcoax is accredited under ISO 17025:2017 and by NPRA Malaysia. We maintain compliance to meet all global regulatory requirements.

Does Alcoax provide Nitrosamines / NDSRI testing?

Yes, Alcoax has extensive experience in developing and validating highly sensitive nitrosamines (NDSRI) testing using LC-MS/MS.

Does Alcoax provide training?

Yes, Alcoax offers training in emerging areas such as Nitrosamine Risk Assessment, Elemental Impurities Risk Assessment, Pharmaceutical Polymorphism, Stability Studies, Comparative Dissolution Profiles, ICH Guidelines, Method Validation, and more.

Does Alcoax provide consultations?

Yes, Alcoax’s leadership has over two decades of proven experience in pharmaceutical analytical research and development. We offer consultations across various areas—please contact us for any specific needs.

Does Alcoax provide stability testing?

Yes, Alcoax has fully cGLP-compliant infrastructure to conduct regulatory stability studies and photostability studies.

FAQ’s

Common Questions About Our Services

Have questions about our services or processes? Explore answers to common queries regarding testing, sourcing, and regulatory support at Alcoax Laboratories.