Bioequivalence Studies Job in Ipca Laboratories Limited

?eviewing BE study protocols received from CRO and ensuring its completeness with respect to scientific and regulatory requirements.
?eviewing in vitro dissolution data received from R & D in line with the available guidance.
?eviewing draft and final BE study report and ensuring its correctness as per applicable regulatory requirements.
?aintaining BE study related documents for respective studies.
?erform monitoring visit at CRO to verify source documents.
?onitor the progress of study and ensure the timelines as per the agreed task order.
?inalizing study specific task order with the selected CROs.
?o-ordinate with the CROs for proper execution of BE studies.
?esponsible for handling regulatory queries.
?esponsible for overall conduct and management of BE activities.
?o-ordinating for import license and BE NOC with the regulatory team.