Druva Chowdary Nagandla
Manager, Cmc @Premier Research
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WORK HISTORY
Manager, Cmc @Premier Research
NC, US
EDUCATION
Lincoln University College
Doctor of Philosophy - PhD, Pharmaceutical Sciences
UC James L. Winkle College of Pharmacy
Master's of Pharmaceutical Sciences in Drug Development
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor's of Pharmacy, Pharmaceutical Sciences
ABOUT DRUVA CHOWDARY NAGANDLA
I am a highly driven, target-oriented professional with extensive expertise in regulatory affairs and CMC expertise. My track record demonstrates a consistent ability to achieve results. As the primary point of contact for CMC matters with Health Authorities and/or Operating Companies, I offer pharmaceutical and regulatory CMC guidance crucial for the advancement of drug development initiatives across various projects.My responsibilities encompass reviewing regulatory and technical documentation, offering strategic insights on drug products and combination programs, and spearheading FDA interactions. I am adept at crafting and evaluating supporting CMC documents, and I actively engage in meetings between sponsors and the FDA to ensure alignment with project objectives.Moreover, I provide strategic evaluations of pharmaceutical and regulatory CMC feasibility for product development prospects, collaborating closely with other technical departments. Within my portfolio, I have effectively overseen intricate Formulation projects in alignment with organizational goals, steering both technical and business development endeavors for pharmaceutical products catering to domestic and international markets.
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