Prakash Gayakwad
Assistant Manager @Umedica Laboratories Private Limited
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WORK HISTORY
Assistant Manager @Umedica Laboratories Private Limited
Navi Mumbai, IN
EDUCATION
North Maharashtra University
Master of Pharmacy, Pharmaceutics
Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner
B.Pharmacy
N.H.Ranka Highschool and Jr.College,Bodwad
H.S.C, Science
SKILLS
ABOUT PRAKASH GAYAKWAD
Expertise in the end-to-end development of solid oral dosage forms- IR/MR tablets, capsules, pellets and POFS-with a strong focus on 505(b)(2), First-to-File (FTF), Subsequent-to-File (STF), and Paragraph regulatory pathways.Experienced in steering complex product development projects for global markets including the US/EU/WHO/US-PEPFAR and extending it to Canada, Australia and ROW/emerging regions. Skilled in integrating science-driven formulation/process design and optimization using Design of Experiments (DoE), and stability programs aligned with ICH standards.Proficient in managing scale-up, technology transfer, validation, and commercial manufacturing, while ensuring quality by design (QbD) principles guide all development activities.Expertise in handling regulatory/agencies queries with precision, ensuring timely responses aligned with submission timelines and strategic goal dates. Driving compliance and operational excellence across pharmaceutical workflows. Passionate about driving innovation, regulatory excellence, and cross-functional collaboration to bring safe, effective, and compliant pharmaceutical products to market.
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