Kay Olmstead

Chief Executive Officer

Nano PharmaSolutions, Inc.

$400

Requested Donation

Kay's Summary

Visionary founder of Nanoformulation Platform Technology: solubilizing BCS Class 2&4 drugs. Patent holder for five FDA approced drugs. Formulation development, Chemical development, Quality Oversight, CMC regulatory expert. Authored CMC sections of 5 NDAs, 1 MAA & 20 IND, IMPD and CTAs. Regulatory Operation (publishing) of eCTD submission to FDA Project Management: proficient with Microsoft Project and PM tools Drug Substance Process Development and GMP Manufacturing Finished Dosage form manufacturing and packaging Outsourcing Management Formulation and Pharmaceutical Product Development (spray drying, solid dosage forms, CR formulations) Vendor/CMO Quality Compliance Audit Intellectual Properties (literature searches, patent review, filing draft) US/Canada/EU Regulatory laws and regulations (cGMP and DMF/IND/IMPD/NDA) Technical Due Diligence Audit & Quality Audit of API/Drug Product CMO's Managing interdisciplinary teams (Clinical and Preclinical, RA/QA, Manufacturing and Development)

About Kay

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