QUALITY CONTROL SOLUTIONS

• Analytical Method Development And Validation

  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.

• Membrane Filtration Method For Productive And Reliable Bioburden Testing

  Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.

• Thermal Analyzers For The Most Demanding Biopharma Applications

  Measure heat flow, weight loss, dimension change, or mechanical properties as a function of temperature.

• Pharmaceutical Package Integrity Testing

  The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

• Connected Execution And Trusted Data For Sponsor-Ready Results

  Bioanalytical organizations are responsible for generating accurate, reproducible data that supports development decisions, regulatory submissions and ultimately faster drug approvals. As sample volumes grow and studies become more complex, maintaining quality, compliance and efficiency can become increasingly difficult.

• Intuitively Simple HPLC System
• Reliable Solution For Verifying Glove Integrity In Pharmaceutical And Biocontainment Environments
• Cell & Gene Therapies: Automating the Future of Regenerative Medicine
• Package Integrity Testing Systems For Tyvek and Porous Packaging