Prakashkumar Raval

Led cross-functional project teams across R&D, QA, regulatory, and production to deliver end-to-end pharmaceutical projects. Executed regulatory strategies aligned with ICH/GMP and prepared submission-ready documentation for global markets.

Managed the development of multiple new chemical entities (NCEs) and coordinated technical data and submission planning for FDA, EMA, and MHRA regulatory filings. Acted as project lead and scientific liaison across departments, ensuring collaborative goal alignment.

Developed detailed project roadmaps for antipsychotic API development, defining scope, timelines, and deliverables. Managed the full lifecycle of tech transfer documentation to scale lab research to commercial production sites.

Executed a cost-reduction project on antihypertensive drugs, achieving a 25% reduction in manufacturing cost through alternate synthesis pathways. Successfully delivered the validation and QA submission of an antidepressant drug process, working independently.

Independently completed a critical anticonvulsant project under staff shortages and deadline pressure. Achieved successful validation and QA submission of an antidepressant drug process.

Completed key modules in formulation of pharmaceutical and biopharmaceutical products, research skills, and characterisation methods. Studied pharmaceutical manufacturing, emerging technology, quality assurance, regulatory affairs, leadership, and project management.

Activities and societies: Industrial project on manufacturing of inorganic chemicals at GHCL (Gujarat, India)

Focused on unit operations, stoichiometry, chemical process industries, and advanced organic chemistry. Studied reactor dynamics, process instruments, technology of petrochemicals and polymers, material science, energy technology, process controls, industrial management, and safety. Completed an industrial project on manufacturing inorganic chemicals at GHCL.

Grade: First Class

Completed modules in industrial chemistry (1 to 6), chemistry, physics, and English. Achieved a first-class pass in all modules.