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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.
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.
Mock FDA Audits
Are you fully prepared for an inspection at your facility?
Our team of experienced ex-FDA investigators offer comprehensive Mock FDA Audit services to help you prepare for an actual FDA inspection. Our team of experts will conduct a thorough inspection of your facility, review your documentation, and provide you with valuable feedback on areas that need improvement to ensure compliance with FDA regulations – both remotely and on-site.
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The Lachman Consultants Blog
The latest on industry compliance, regulatory affairs, technical services, and a whole lot more.
Root-Cause Analysis in API Manufacturing: Avoiding Recurring Deviations
Breast Biopsy Needles Are in Short Supply – What Will the Impact be on Patient Care?
June 2026 Mid-Month Unofficial Approval Actions
Modification to iPLEDGE Program Implementation Delayed to November 2026
From Guidance to Reality: Building a Visual Inspection Program that Holds Up
