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Lachman Consultants has a reputation for demonstrated excellence in technical, regulatory consulting, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
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Lachman Consultants’ Regulatory Affairs group is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. Their goal is simple; provide simple workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.
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The Lachman Consultants Blog
The latest on industry compliance, regulatory affairs, technical services, and a whole lot more.
Change At the Top at OGD!
A New Morale Hit at FDA on Employee Performance Evaluation
The Question for AI: Not “Does It Work?” but “Can You and FDA Find It Trustworthy?”
Great Science Isn’t Enough: Shared Insights by the CBER Director at ARMs Meeting on the Mesa
FDA Official August 2026 Monthly Stat Report and Unofficial September Approval Numbers
