ALFATESTLAB: trusted analytical expertise in Pharmaceutical Analysis

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Alfatestlab empowers pharmaceutical innovation with ISO 17025 and GMP-certified contract analyses and method development, leveraging advanced tools such as MDRS, laser diffraction, BET surface area analysis, XRD, rheology, and DSC/TGA thermal profiling. From solid state characterization to bioequivalence studies, we deliver rapid, accurate insights ensuring regulatory compliance and accelerating product development.

For over a decade, Alfatestlab has been redefining standards in materials characterization, combining scientific expertise with cutting-edge technologies to empower the pharmaceutical industry. Founded in 2014 as the contract laboratory division of Alfatest—a long-standing distributor of world-class scientific instrumentation—Alfatestlab has evolved into a trusted partner for companies seeking reliable, fast, and comprehensive analytical solutions.

Today its portfolio of services bridges the critical gap between research and regulatory compliance, ensuring that products are characterized, validated, and brought to market with the highest standards of quality.

Alfatestlab was established to offer more than contract analysis. From the outset, the company’s vision was to combine state-of-the-art instrumentation with exceptional expertise, transforming its demonstration center into a full-scale ISO 17025-accredited and GMP-certified laboratory. This evolution has been fueled by Alfatestlab’s continuous commitment to staying at the forefront of analytical science.

With over 60 pharmaceutical companies in Italy already relying on Alfatestlab’s services, the laboratory has become a cornerstone for research and quality assurance. Its expertise extends across a wide spectrum of sectors, from biopharmaceuticals, biotechnology, and cosmetics to food and beverage, energy, polymers, electronics, and nanotechnology. This versatility not only reflects the laboratory’s technical capabilities but also its ability to adapt to the evolving demands of highly regulated industries.

Alfatestlab’s range of analytical services covers both materials characterization and biosciences (for further info www.alfatestlab.com).

For solid-state and material characterization, Alfatestlab specializes in: 

• Particle size and shape – using advanced tools like the Malvern Panalytical Mastersizer and Morphologi 4-ID, combining laser diffraction and Morphologically Directed Raman Spectroscopy (MDRS), in addition to electron microscopy, dynamic light scattering, dynamic image analysis, and much more
• Surface area and porosity (BET analysis) – providing crucial insights into the micro, meso, and macroporous structures of powders and solids.
• Powder and rotational rheology, surface tension and viscosity studies – vital for understanding flowability, stability, and processing behavior.
• Thermal analysis (DSC/TGA) – characterizing melting points, crystallization behavior, glass transitions, and polymorphs to ensure drug stability and compatibility.
• XRD and XRF – supporting crystal structure, complex formulation analysis and contamination detection.

In biosciences, the lab offers equally advanced capabilities:

• Biomolecule size, charge, and stability assessment, including aggregation and conformational changes.
• Nanoparticle characterization for advanced drug delivery systems, using DLS, NTA, zeta potential measurements
• Microfluidics production of nanoparticle for nanomedicine application, including method development
• Extracellular vesicle (EVs) characterization, including size, concentration, cargo and phenotype determination.

Beyond routine testing and batch release analysis, Alfatestlab is renowned for its ability to develop, validate, and transfer analytical methods under GMP conditions. This expertise proves particularly valuable when working with challenging or novel samples that require tailored solutions.

One of Alfatestlab’s core strengths is its ability to deliver high-quality analysis with rapid turnaround times. Standard reports are issued within 10 working days, while express reports are available in as little as 2 days—a critical advantage for pharmaceutical companies under tight development and regulatory timelines. 

Moreover, the laboratory’s state-of-the-art instrumentation enables precise and reproducible results, helping clients optimize their formulations, troubleshoot production challenges, and improve the bioavailability and stability of their products. Whether it’s raw material control, generic drug bioequivalence studies, or troubleshooting batch variability, Alfatestlab provides actionable insights that save both time and resources.

Alfatestlab’s expertise in MDRS technology has made it a reference point for in-vitro bioequivalence (IVBE) studies, which are increasingly critical for generic drug development. MDRS combines automated image analysis with Raman spectroscopy to distinguish the particle size and chemical identity of each component in complex formulations, including creams, gels, and suspensions. This capability provides pharmaceutical companies with a robust scientific foundation for regulatory submissions, particularly for FDA Q3 requirements.

Alfatestlab’s growth story is built on a foundation of trust, technical excellence, and an unrelenting drive to innovate. With a highly skilled team of scientists, a unique set of analytical techniques, and the backing of a leading instrumentation distributor, Alfatestlab is poised to continue its expansion in the pharmaceutical sector and beyond. 

The laboratory’s mission is simple yet powerful: to provide results you can trust. This promise is reflected not only in its technical capabilities but also in its customer-centric approach, which prioritizes clear communication, data interpretation, and tailored solutions.

Pharmaceutical companies seeking a reliable, expert partner for materials characterization, bioequivalence studies, or advanced bioscience analysis will find in Alfatestlab a dynamic and forward-thinking ally.