INSIGHTS ON QUALITY CONTROL

  • ICH Q9 Revision 1: Enhancing Quality Risk Management
    8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  • Optimizing Contamination Control: Strategy Planning And Execution
    7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  • Aseptic Expertise And Delivery Of Services
    8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  • Method Migration Of A Normal Phase HPLC Method For Tocopherols
    9/17/2024

    The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.

  • Manufacturing Solutions
    3/4/2025

    Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.

QUALITY CONTROL SOLUTIONS

  • Lateral Flow API Weighing and Dispensing Enclosure designed to provide personnel and product protection when weighing 0.5 kilograms (kg) of API powder.

  • Flow Sciences, a leading provider of containment solutions for laboratory, pilot plant, and manufacturing facilities consults with third party industrial hygienists to conduct in-house Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure customers’ products perform at the level they need.

  • 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.

  • Our highly skilled team of chemists and process engineers, combined with a science-driven project management approach, ensures seamless execution at every stage.

  • Ensure your equipment meets stringent regulatory expectations with an instrument qualification service that supports you through installation, maintenance, and modifications for compliance.