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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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As long-standing leaders in technical and regulatory consulting services, Lachman Consultants provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.
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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.
Mock FDA Inspections
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Our team of experienced ex-FDA investigators offer comprehensive mock FDA inspection 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.
Are You Still Using Your Grandma’s Container-Closure Integrity Approach?
Final Rule on IVDs Issued, Along with Two Guidance Documents
New ISPE Guide on 503A Compounding
Q1/Q2 Formulation in Labeling Gets Promoted in New FDA Guidance Addressing Components and Composition in NDA and ANDA Applications
Review of Biosimilar Market – Pricing and Uptake
