Alan Donald, MS, MBA, RAC, FRAPS
Integrated Scientific & FDA Regulatory Expert Witness
Objective scientific and FDA regulatory analysis for complex litigation and product development involving FDA-regulated products.
(619) 208-5624 | adonald@matrixmedcorp.com | San Diego, California
For more than 50 years, I have helped attorneys, companies, investors, and biomedical innovators evaluate and resolve complex scientific, manufacturing, quality, and FDA regulatory issues involving medical devices, pharmaceuticals, biologics, diagnostics, dietary supplements, OTC products, and combination products.
While attorneys often retain multiple experts to evaluate scientific, manufacturing, quality, medical product development, and FDA regulatory issues, my integrated expertise enables counsel to obtain objective scientific and FDA regulatory analysis through a single expert.
Why Attorneys Retain Me
Determine what happened, why it happened, and whether the available scientific, technical, and FDA regulatory evidence supports the opinions being offered.
- Scientific and technical evaluation
- FDA regulations and regulatory strategy
- Medical product development
- Manufacturing and Quality Systems
- Failure analysis and root cause investigation
- Product labeling and warnings
- Clinical studies and post-market surveillance
- Standards of care and industry practice
Representative Areas of Expertise
Medical Devices
Design, manufacturing, quality systems, FDA regulation, failure analysis
Pharmaceuticals & Biologics
Clinical development, labeling, safety, FDA regulation
Dietary Supplements & OTC Products
FDA compliance, formulation review, labeling, GRAS
Diagnostics & Combination Products
Product classification and regulatory strategy
Advanced Therapies
Cellular technologies and regenerative medicine
Expert Witness Services
Objective scientific and FDA regulatory analysis, expert reports, deposition, and trial testimony
Expert Commentary
Discuss Your Matter
Whether you require an expert witness, an FDA regulatory assessment, or an independent scientific evaluation, I would welcome the opportunity to discuss your matter and determine whether my background is an appropriate fit.