BLPL’s regulatory and quality support teams support partners in developing validation master plans, batch records, investigation reports, validation summaries, annual products review and Drug Master Files.

Key areas of focus includes:

  • Analytical method development

  •   Degradation / Stability studies

  •   Analytical method validation

  •   In-process/ intermediate/final product analysis

  •   Method transfer to multi-side
 

 Impurity profiling:

  • Team of experienced organic chemists to  synthesize milligram to multi-gram scale of compounds

  • Experienced scientists for identification and characterization of novel chemical entities using modern methods of analysis

  • Identification, structure elucidation and characterization of impurities

  • Degradation study to prove the method developed is stability indicating

  • Photo stability studies as per ICH guidelines

  • Real time and Accelerated stability studies as per ICH guidelines
 
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