Analytical Method Development

Before any testing is conducted on any pharmaceutical product, a “method” must be developed. The method is a formal document governing the steps and materials required to properly test the product for certain characteristics, such as particle size, compressibility, relative amounts of each ingredient, and various other physical and chemical attributes. The exact method is bound by the pharmaceutical itself, laws of chemistry and physics, federal regulations, and the manufacturer.


Developing a method which tests for the necessary characteristics to meet all relevant regulations is a technically demanding and rigorous process which must be handled properly and ethically.


BRS Analytical Services brings both depth and breadth of experience in the complex scientific and complicated legal aspects of pharmaceutical development. The customers of BRS Analytical Services will find a knowledgeable, ethical, and adaptable partner on whom they can rely.

Some of our services include:

  • Method Development

  • Method Validations

  • Method Verifications

  • Method Transfer Activities

  • Cleaning Method Development

  • Forced Degradation

  • Excipient Compatibility 

  • Deformulation of Reference Listed Drugs (RLDs)

 

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