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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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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.
Pharmacy Compounder Problem with Use of Dietary Grade Glutathione
Etomidate Under Review for Controlled Substance Classification
BsUFA 2027 Fee Invoices on the Way!
More Product Specific Bioequivalence Recommendations Hit the Press
FDA Issues Final Guidance on Therapeutic Equivalence
