Female chemist dropping a chemical substance into another substance

Analytical Method Development & Testing

Drug Products, Active Pharmaceutical Ingredients (API) and related items are tested as per the analytical methods that are either generally accepted across the industry or as specified by the highest authorities.

Physical characteristics, drug stability and other factors are few of those checks that save a drug against submission delays, approval delay and delayed commercial drug development. Early Phase Clinical Trials need to be performed in an Analytical Chemistry Laboratory and Analytical method Development, Testing, Validation and transfer becomes vital because of the purpose they serve:

  • Assess the API

  • Determine the composition of drugs

  • Perform Quantitative and Limit Tests for impurity content & control

  • Compound Testing + Assigning of right equipment and resources

  • Development of SOPs for Routine executions

  • Working as per ICH Guidelines

  • Working as per GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practices) And many other important tasks.

Analytical Methods gain huge significance for biotech and pharmaceutical companies, because these are too critical from the viewpoint of regulatory, commercial and patient safety guidelines. That’s the exact reason behind our efforts invested into developing impressive procedural knowledge and capabilities in our teams and our Analytical Chemical laboratory that delivers the best analytical method development and research expected from an expert Contract Research Organization like BioLink Lifesciences.