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Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA consultants and industry experts has offered compliance, regulatory affairs, and science & technology services to clients around the world.
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Lachman Consultants’ comprehensive list of services extends to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
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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.
Unofficial March 2026 ANDA Approval Actions Keep on Pace
When Your CDMO Changes Hands: Quality and Compliance Concerns in an Era of CDMO M&A
GDUFA IV Negotiations Continue as the Clock Ticks On
First NME Approved through Commissioners National Priority Voucher (CNPV) Program
FDA’s Quarterly Monthly Listing of Potential Signals of Serious Adverse Events and Risks
