We at apicule specialize in analytical method development for pharmaceutical APIs, creating validated methods for assay, dissolution, impurity profiling, and stability testing. Our expert team ensures regulatory compliance with ICH Q2(R1) and supports both early development and commercial submissions.
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...
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...
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...
