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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.
MEDICAL DEVICE/COMBINATION PRODUCTS
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.
BIOLOGICS
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.
REGULATORY AFFAIRS
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 June Mid-Month Peek at ANDA Approval Actions
Another Bite at the Apple!
Unofficial May 2025 ANDA Approval Actions—Looks Like a Win!
FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report—Big Time
Minor Dosage Form Changes to OTC Monograph Products Contemplated by Draft FDA Guidance
