Nancy Harper
Consultant at Pharmaceutical Advisors Llc
Based in Sumter, United States
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Seniority
Staff
Department
General Business & Management
Location
Sumter
Industry
Pharmaceutical Manufacturing
Company size
8
Contact information
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n•••••••@pharmadvisors.com
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Background
About Nancy Harper
Accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and inhalation products. Unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met. Expert in commercial drug product design and development, application of Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, technical risk assessment and problem solving. Key contributor as formulator or pharmaceutical expert to the development and successful commercialization of 10 new drug products. Experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets. Specialties: Formulation design and development, Technical risk assessment, Process development and scale-up, Technical due diligence for business development, CMC regulatory strategy, Data analysis and interpretation, CMC submission component authorship, Life cycle management
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