Akshay User

I'm pursuing an M.Pharm in Regulatory Affairs at Kishoritai Bhoyar College of Pharmacy, Kamptee, with academic knowledge of CTD structure, CMC Module 3, and regulatory requirements for US, EU, and ROW markets.

My studies cover post-approval changes, change-control evaluation, regulatory impact assessment, and submission grouping concepts. I'm familiar with ICH Q8/Q9/Q10, GMP principles, and QMS documentation.

As a Quality Control Intern at Relief Laboratories, Nagpur, I assisted with laboratory testing in accordance with GMP and SOP requirements. I also gained exposure to quality documentation, analytical records, and sample handling.

For an academic project, I formulated a herbal nutraceutical jelly with Shankhpushpi and almond extracts, developing and evaluating three trial batches. I reviewed literature on the ingredients and documented the formulation development and evaluation process.