Pratibha Bhat
Sr Biologist Sr Cmc Reviewer,opma Opq Cder at Fda
Based in Frederick, United States
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Seniority
Staff
Department
Science
Location
Frederick
Industry
Government Administration
Company size
17K
Contact information
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p•••••••@fda.gov
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Background
About Pratibha Bhat
Scientists with more than 20years of professional experience in the pharmaceutical industry, encompassing positions of varied responsibility with focus on pre-formulation, formulation development, technology transfer, scale-up and business development.* Expertise in developing Solid oral dosage formulations (Immediate Release, Delayed Release, Extended Release and Rapidly Disintegrating Formulations) and performing pre-formulation and stability studies for the drug product under research and development phase as per ICH guidelines.* Expertise in developing controlled drug substances especially (Schedule-II drugs) with all required DEA (Drug Enforcement Agency) documentation.* Extensive skills with process development and technology transfer of products from R&D scale to manufacturing/commercialization scale.* Involved in Designing of Clinical Study Protocols (Bio-equivalence studies)* Experience in Interpreting and Analyzing Clinical Data * Extensive Experience in understanding technical and market trends and initiate pro-active product development programs as required Specialties: Research and Development, Drug Design and Delivery, Process and Product Validation, Regulatory Filing, Technical Support to Business Development, Intellectual Property Management, Technical Documentation
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