Method Development & Method Validation

As per FDA, Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. The analytical procedure refers to the way of performing the analysis. It describe in detail steps for necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. By help of deferent analytical tool we developed to new method and which is much accurate and presised. Sadguru Lab support customers at various stages of the development and validation process. Sadguru   Lab have competent team who are expertise in optimization of existing research methods, full development and validation studies, and transfer of previously validated methods, we offer the best expertise in our field to support your needs.

• Feasibility, Qualification and Validation of methods to assess the quality of your manufacturing process and your product
• Transfer of methods previously validated
• Compendial method verification studies