Niharika Bathula

Proficient in current Pharmaceutical regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.

Masters Project: Navigating Pharmaceutical Regulatory Landscape In South Africa: An Analysis of Initial Dossiers and Deficiencies

• Prepared a well-structured Dossier format aimed at minimizing deficiencies in accordance with SAHPRA requirements by considering recognized regulatory authorities of SAHPRA.
• Identified common deficiencies observed in dossiers submitted to SAHPRA and categorized them as either avoidable or unavoidable before submission through a comprehensive examination of regulatory requirements and industry standards.
• Provided insights into potential strategies for pharmaceutical companies to minimize deficiencies in their dossier submissions to SAHPRA.

Graduation Project: Pyrazole Derivatives as Inhibitors of Aurora Kinase, a potential drug target in cancer

• Presented "Cross-sectional research on regulatory licensing of novel medical devices" at the 72nd Indian Pharmaceutical Congress, Nagpur - 2022 & Pharmaquora, Manipal, Karnataka - 2022.

• GPAT - AIR 4678, 2022.
• NIPER - AIR 923, 2022 .
• Manipal Entrance Test (MET) - AIR 87, 2022.

• Drug Discovery
• Drug Development
• Drug Commercialization

• Date of Birth: 01/30/99
• Nationality: Indian
• Languages : English, Telugu, Hindi