– End to End service for the Bio-Equivalence (BE) study from Planning of BE study till submission of Dossier to the Agency.
– Assessment of sample size and Cost Analysis for Bio-Equivalence study.
– Initiation, review and finalization of BE study Protocol.
– Application for BE NOC and Test licence application from CDSCO (India).
– Monitoring of BE study and preparation of Monitoring Study Report.
– Review of Bio-Equivalence documents like Case Record Form (CRF), AE, Deviation and Source Document.
– Review and finalization of Clinical, Bio-Analytical and Pharmacokinetics Statistical study report.
– Handling and response to critical queries raised by Regulatory Agency
– Compilation of Document in eCTD format