Over 14+ experience within Pharmaceutical Research & Development (R&D)
Enriching experience of clinical trials (Phase 2 to Phase 4) design and conduct
Clinical trial Project Management experience
SAS and clinical data analysis
Preparation of clinical trial reports as per ICH E3
Calculation of release profile for modified dosage forms and development
Pharmacokinetics analysis of data
Preparation & submission of regulatory dossiers as per ICH CTD- Module 1, 2.4, 2.5, 2.6 and 2.7
Preparation and review of PDE reports for cleaning validation of active pharmaceutical ingredients
Design and conduct of BA/BE studies. Monitoring and project management experience.
Design and conduct of po...
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