Regulatory agencies like the FDA, EMA, and ICH have set stringent guidelines for analytical method development to ensure drug safety and efficacy. Compliance with these regulations is critical for pharmaceutical companies aiming to secure approvals for their products. Key Regulatory Requirements Documentation & Submission The Future of Regulatory Compliance With advancements in AI-driven analytical tools […]...
When developing analytical methods for pharmaceuticals, two critical aspects must be considered—validation and verification. While both ensure the accuracy and reliability of analytical techniques, they serve distinct purposes. Understanding their differences is essential for maintaining regulatory compliance and product quality. What is Analytical Method Validation? Analytical validation is the process of proving that a method […]...
Analytical method development is a critical aspect of pharmaceutical research and quality control. It ensures the accurate identification, quantification, and characterization of drugs and their components. A well-developed analytical method provides consistent, reliable, and reproducible results, making it essential for regulatory approval and product safety. Steps in Analytical Method Development By following these steps, pharmaceutical […]...
