At Bion Clinical Pvt. Ltd., I prepared, reviewed, and quality-checked Bioavailability/Bioequivalence study documents, including protocols, informed consent forms, case report forms, and clinical study reports.
I also assisted with regulatory dossier compilation, including eCTD documents, and coordinated Ethics Committee submissions in line with ICH-GCP and applicable requirements.
My work included maintaining regulatory documents for product registration, clinical trials, and post-approval submissions, with attention to completeness, version control, and data integrity.
My pharmaceutical research includes developing and evaluating an atorvastatin calcium tablet formulation using inclusion complexation to improve dissolution, alongside publications and projects on drug delivery and pharmaceutical formulation.
