Ready to optimize clinical dose and meet compliance standards for entry into target markets?

My expertise extends beyond development into comprehensive regulatory and clinical readiness, ensuring products not only perform as intended but also meet all necessary approval standards.

• Aerosol Characterization for Development and Regulatory Approval: From early development to final approval, I conduct and interpret aerosol characterization data according to ISO27427, FDA USP<501>, and <1501> standards, providing critical insights to drive clinical and regulatory success.

• Target Dose and Patient Population-Specific Analysis: For companies aiming to demonstrate efficacy in specific patient groups, I deliver tailored clinical dose estimations and analysis, optimizing product positioning and approval potential for defined target populations.