Former FDA — Generic Drug Division
Joseph MastronardyPh.D.
Guides regulatory submissions and QC method validation; served in the Generic Drug Division while at FDA.
- ANDA
- NDA
- PMA
- Method Validation
- QC Laboratory
25+ years FDA and industry
Background
Dr. Joseph Mastronardy has more than 25 years of both FDA and industry experience. He is an expert in providing guidance on regulatory submissions — ANDA, NDA, PMA, FD-483 responses, consent decrees, supplements and annual reports — and in writing regulatory SOPs. He worked in the Generic Drug Division while serving the FDA.
He has quality system expertise covering cGMP solutions for both pharmaceuticals and medical devices, conducts validity assessment audits, and assists in developing QC laboratory specifications and method validations. He is known for assessing issues quickly and implementing quality systems that pass FDA scrutiny.
What Joseph does on an engagement
- ANDA, NDA and PMA submission guidance
- Regulatory SOP authoring
- Validity assessment audits
- QC specification development and method validation
- Annual reports and supplements
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