Bilkis Amthaniwala

I’m a regulatory affairs professional with a lab-to-regulatory perspective, bringing scientific rigor to assess compliance gaps that purely regulatory candidates can miss. I specialize in regulatory documentation control, audit-ready record keeping, and validation support for analytical environments.

In my current role as a Core Laboratory Lab Analyst, I maintained documentation systems aligned with ALCOA+ principles to ensure complete data integrity and traceability across analytical records. I also supported audit preparation by organising regulated documentation and generating GLP-compliant analytical data packages suitable for regulatory submission support.

Previously, as a Lab Assistant at King’s Centre for Pharmaceutical Medicine Research, I assisted in generating and reviewing analytical data packages aligned with GLP and regulatory reporting standards. I also contributed to distinction-graded GLP-1 nanoparticle formulation research by generating regulatory-grade analytical data packages.

My experience also includes ISO/GLP-compliant microbiological and PCR-based testing across 100+ samples at Advance Biotechnology Centre UAE, with strict SOP compliance and traceable laboratory records. I bring working knowledge of ICH guidelines, EMA/WHO standards, and GCC submission requirements across UAE (MOHAP), Saudi Arabia (SFDA), Kuwait, and Oman—grounded in CTD dossier structure and lifecycle documentation aligned with regulatory expectations.