INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.

  • Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.

  • Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).

  • In pharmaceutical testing, the development and validation of analytical methods are absolute musts when it comes to reliable quality control. Natoli Scientific is at the forefront of offering comprehensive analytical method development and validation services designed to ensure the integrity of your company’s drug formulations. Our expert team develops robust methods tailored for each unique compound, with an approach that emphasizes precision, accuracy, sustainability, and compliance with regulatory standards such as the FDA and ICH guidelines. These methods are meticulously validated to confirm their reliability across a range of analytical parameters including specificity, sensitivity, linearity, and reproducibility.

    This validation process is critical for verifying that our methods produce consistent, trustworthy results throughout the product’s lifecycle, thus fostering confidence in the safety and efficacy of pharmaceutical products.

  • Learn about a custom chemical bulk packaging service that offers high-purity raw materials in precise amounts in a variety of ready-to-use configurations for cGMP manufacturers.