Hire Dipak Bhandurge, a pharma consultant specializing in Clinical Studies, Drug Development and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dipak Bhandurge is a regulatory affairs consultant with 16 years of experience in Chemistry, Manufacturing and Controls (CMC), regulatory strategy, product registration, and lifecycle management for global markets. His expertise includes regulatory filing, change control assessments, and CMC support for oral solid dosage forms, sterile injectables, vaccines, biologics, and small molecules. He helps pharmaceutical teams coordinate submission requirements, assess regulatory impacts of product changes, and maintain consistent documentation throughout product development and commercialization.
Dipak provides regulatory and CMC support for biologics and vaccines. His experience includes vaccine CMC authoring, document review, pre-IND meeting preparation, and IND submissions. He helps development and regulatory teams organize technical information, coordinate submission activities, and address documentation requirements for development-stage and registration projects.
Dipak supports the regulatory assessment of pharmaceutical change controls and associated post-approval submissions. His experience includes reviewing proposed changes against registered product information, coordinating with country affiliates, and planning submission requirements. He helps organizations understand the regulatory implications of changes and organize the documentation needed for variations, supplements, and other lifecycle activities.
Dipak supports CMC regulatory strategy, document authoring, and technical review for pharmaceutical products and vaccines. His experience includes reviewing manufacturing and quality information, preparing CMC content for development and registration submissions, and addressing health authority queries. He helps cross-functional teams compile consistent documentation and coordinate CMC deliverables throughout product development and lifecycle management.
Dipak supports regulatory registration and lifecycle management for oral solid dosage products. His experience includes dossier preparation and review for the US, Canadian, European, and Chinese markets, alongside generic product submissions and post-approval changes. He helps teams assess regulatory documentation, coordinate responses to agency queries, and maintain consistency between product changes and registered information.
Dipak supports regulatory submission preparation and management for the US, Europe, Canada, China, and other markets. His experience includes ANDA, NDA, IND, and vaccine submissions, alongside post-approval changes and deficiency responses. He helps teams review dossier content, plan submission activities, coordinate with country affiliates, and prepare responses to health authority questions.
