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Toxicology studies to comply with GRAS and NDI


  • 01Proactive planning ensures efficient risk management before, during and after the study.
  • 02Each study is run by a dedicated Study Director and conducted by toxicologists with the right qualification, training and experience.
  • 03Independent quality assurance systems and checks guarantee consistent compliance with regulatory guidelines.
  • 04An audit trail ensures complete access to raw data generated during the study.
  • 05Efficient cold chain maintained with data logger if organs or tissues are called for after the study.
  • 06Allied services like test item stability, impurity analysis and formulation development also available.


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Document generation and control

Selection and training of Study Director and team

Test item import and determination of best dosage form

Dose finalization after balancing ethical norms and study objectives

Animal selection, randomization and grouping

Facility inspection and qualification

Documentation audit and corrections

Master calibration of all instruments

Submitting reports at scheduled intervals

Double data entry

Analysis of biochemistry, histopathology , clinical chemistry using sensitive high-end instrumentation

Independent, comprehensive QA review of compliance

Publication for GRAS affirmation, NDI notification