The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based approaches to validation using CSA and ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

PMI’s FDA-approved SynCardia STAH is promising, but adoption and revenues lag; cash burn and dilution weigh. Read the full ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

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The FDA has delayed an approval decision for Aldeyra Therapeutics’ lead dry eye disease candidate, adding another detour to the candidate’s winding road to potentially enter the market. At a Dec. 12 ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the recently published FDA ...