Piyush Mandloi

I’m a B.Pharm graduate (RGPV, 2026) trained in CTD/eCTD dossier preparation, global drug registration frameworks, and ICH guidelines (Q1A–Q11, E2A–E6). I also work with cGMP/GLP quality systems, pharmacovigilance, and clinical research methodology—always with a document-first mindset.

I’m certified in ICH-GCP E6(R3), and I focus on regulatory-quality execution: structured SOP and regulatory documentation, CAPA & deviation management, and pharmacovigilance/ADR reporting practices. In my Pharmacy Operations & Regulatory Documentation internship, I maintained SOP-compliant prescription registers and GDP-aligned inventory using ALCOA+ data integrity principles.

I contributed by verifying drug schedules and checking product labelling against CDSCO packaging compliance standards, then produced technical observation reports built to mirror regulatory submission workflows. I also co-authored a peer-reviewed formulation study where I ran a full ICH Q1A stability programme and created GMP-aligned Batch Manufacturing Records structured as a CTD Module 3 development package.