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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.
December 2024 Brought Gifts for ANDA Approval Actions (Unofficially)
Logbook Review: Too Simple To Automate?
The Tirzepatide Chapter Three Rears Its Head – What Happens Now?
FDA Issues Draft Guidance to Assist in Compliance with 21 CFR 211.110
FDA Updates List of Off-Patent, Off-Exclusivity Drug Products With No Approved ANDAs
