QUALITY CONTROL SOLUTIONS

• Feasibility Studies For Container Closure Integrity Testing Applications

  PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.

• Supel™ BioSPME 96-Pin Devices For Fast And Simple Plasma Protein Binding Studies

  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.

• 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.

• Quality, Compliance, And Regulatory Services For Life Sciences

  The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.

• HACCP Validation Services For Every Aspect Of Workflow Performance

  Ensure peak production safety with a comprehensive audit that validates performance limits and regulatory compliance. Secure the documentation and certification needed for total peace of mind.

• Seal Inspection Technologies for Tablets & Capsules Packaging
• Custom Bulk Packaging For Pharmaceutical Raw Materials
• Membrane Filtration Method For Productive And Reliable Bioburden Testing
• Comprehensive Batch And Lot Testing Services