Nancy J. Harper, Ph.D.

Senior Drug Product Consultant

With over 30 years of industry experience, Dr. Harper is an accomplished pharmaceutical product development scientist with emphasis on development of parenteral, oral liquid and inhalation products. She possesses a unique talent for merging scientific rigor, regulatory expertise, and pragmatism into drug product development while ensuring that customer needs are met.

As an expert in commercial drug product design and development (formulation and manufacturing process), she applies Quality by Design (QbD) concepts, CMC regulatory strategy/authorship, technical risk assessment and problem solving. Nancy is a key contributor to clients as formulator or pharmaceutical expert in the development and successful commercialization of new drug products. She possesses experience with NCE’s (human and veterinary), product enhancements, and generic products for developed and emerging markets.


Core Competencies

  • Parenteral
  • Lyo Formulation
  • Inhalation
  • Oral Liquid
  • FMEA Analysis
  • Gap Assessment
  • CMC Strategy
  • Steriles
  • Nebulizer