Carol DeSain

Carol DeSain's consulting services focus on regulatory compliance for biologic, biotech, pharmaceutical, diagnostic, and combination products. She has worked in the industry for more than 25 years, with start-ups, global corporations, contract manufacturers, and allied industries in the U.S. and Europe. Carol helps her clients with CTD and DMF submissions, establishing new GMP/QSR systems, re-working failing systems, establishing policy for global corporations and training management and staff. She is known for her broad knowledge of the industry, a practical, hands-on approach to compliance, interactive and informative training sessions, and for the books she has co-authored on documentation, risk management, validation and product development.

Prior to consulting Carol worked in basic research (biochemistry, enzymology, and genetics), product/process development, and aseptic pharmaceutical manufacturing.

Carol's practice focuses on combination products, sterile pharmaceutical products, and active pharmaceutical ingredients.

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