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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 has an unsurpassed reputation for excellence in technical, regulatory consultation, and guidance services for the Pharmaceutical Industry, including generic and novel drug products, OTC, and monograph drugs, and many more.
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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.
FDA Proposes to Withdraw Approval of Tavneos NDA After New Information Comes to Light
Office of Compliance Issues 2025 Annual Report
Day Two Helpful Hints from the Generic Drugs Forum 2026
More Tidbits from Day One of the Generic Drugs Forum 2026
A Few Tidbits from the Generic Drugs Forum (GDF) 2026 Morning Sessions
