Abiventhan

About

Enthusiastic M.Pharm Pharmaceutical Regulatory Affairs student with knowledge of CTD/eCTD, NDA, ANDA, IND, regulatory guidelines, clinical studies, and GCP. Interested in regulatory submissions, documentation, compliance, and regulatory auditing.

Experience

• Medical Advisor Intern – Regulatory/Clinical Affairs
  Government Hospital
  Sep 2024 – Oct 2024

Education

• M.Pharm
  JSS College of Pharmacy, Ooty
  Pharmaceutical Regulatory Affairs · 2025 – 2027
• B.Pharm
  Thanthai Roever College of Pharmacy, Perambalur
  Pharmacy · 2021 – 2025

Skills

• XML
• GMP
• GLP
• GDP
• ICH guidelines
• Computer System Validation
• ISO 14971

Projects

• Comprehensive Regulatory Review of ATMP Development and Approval in Europe Countries

  Currently working on a regulatory review of ATMP development and approval in European countries.

• Comprehensive Regulatory Review of Glaucoma shunts and stents in Asian Countries

  Currently working on a regulatory review of glaucoma shunts and stents across Asian countries.

• Comprehensive review of Combretum caffrum molecular docking
  Chemsketch, AutoDock

  Molecular docking study of combretastatin analogues and their interaction with the colchicine-binding site of tubulin to identify compounds with high binding affinity and reduced side effects.

Courses & certifications

• Good Manufacturing Practice (GMP)
• Centre of Regulatory Excellence (CORE)
• Role of ISO 13485 and ISO 14971 in Medical Device Regulation
• Hands-on training on eCTD software

📚 Publications

• Comprehensive Regulatory review of glaucoma shunts and stents in Asian countries
• Comprehenssive Regulatory review of ATMP Development and approval process in Europe Union