Sonali Parab

• Planning and execution of Bioequivalence studies for USFDA, ANVISA and EMA submission

• Review of bioequivalence study protocols, Case report forms, Clinical study reports and CDISC SDTM & ADaM Datasets

• Submission of Bioequivalence eCTD data Module 5 on Dossier-Mgmt© software by Educe solutions

• On site Monitoring of bioequivalence studies Trial Master File, Volunteer screening and other study site related documents

• Facility qualifications audits for selection of CROs

• Preparation of Bioequivalence Trial Information Forms & Clinical Overview & summary

• Review of preclinical animal study, toxicology study and invitro study (Ames Test) plans and reports

• Application of import licences (Form 12, Form CT-16) and manufacturing licences (CT-10, CT-12 & CT-13) on CDSCO sugam portal

• Regulatory query response

• Innovator and generic products procurement from various regulatory markets (US, Brazil, South Africa, Europe etc.)

• CRO and Innovator and generic products payment through SAP financial management software

• Review of pharmacokinetic data and suggest suitable study design for execution of Bioequivalence and drug interaction studies of New drugs and FDCs for EMA and ANVISA submission

• Review of study protocols, eCRFs and results

• Co-ordination with and involved in review of study designed by Clinical Departments of subsidiary's of Sanofi Synthelabo located in various countries

• Literature based evaluation of excipient safety in the proposed prototype of the formulation

• Review of comparative dissolution profiles, biowaivers and other analytical data