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Qual­ity Assurance

Good Lab­o­ra­tory Prac­tices (GLP) compliant:

val­i­dated by ANSM every two years:

  • From Decem­ber 2003 (status“A”), last inspec­tion July 2016
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  • ICH S7A: Guide­line on safety phar­ma­col­ogy stud­ies for human phar­ma­ceu­ti­cals see more
  • ICH S7B: Guide­line on Safety Phar­ma­col­ogy stud­ies for assess­ing the poten­tial for delayed ven­tric­u­lar repo­lar­i­sa­tion (QT inter­val pro­lon­ga­tion) by human phar­ma­ceu­ti­cals (Seen as an exten­sion of S7A) see more
  • Com­pre­hen­sive in Vitro Proar­ry­th­mia Assay (CiPA) ini­tia­tive: com­ing soon see more

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