Accelerating compliance
and approvals with unmatched regulatory insight and experience.

Contact Us Today
The Lachman Difference

The most efficient services.
The most qualified professionals.

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.

Learn More About Us

Stay in the know

Sign up today for the Lachman Consultants blog.

Get the latest news on industry compliance, regulatory affairs, technical services, and a whole lot more.

    AREAS SERVED BY LACHMAN CONSULTANTS

    ADVANCE. CONFIDENTLY.

    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.

    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.

    Learn More About Mock FDA Audits

    OnCall Image

    Recent Posts

    The Lachman Consultants Blog

    The latest on industry compliance, regulatory affairs, technical services, and a whole lot more.

    Considerations When Engaging a Third Party When Addressing Agency Citations

    Considerations When Engaging a Third Party When Addressing Agency Citations

    A firm can face a situation in which it needs to engage a third party,...
    Read More
    FDA Requires New B6 Deficiency Warning on Parkinsons Drug

    FDA Requires New B6 Deficiency Warning on Parkinsons Drug

    On March 20, 2026, the FDA issued a Warning (here) notifying healthca...
    Read More
    OGD Releases Official February 2026 Statistical Report

    OGD Releases Official February 2026 Statistical Report

    Last night, the FDA published the Generic Drugs Program Monthly and Qu...
    Read More
    GDUFA IV Negotiation Session Minutes

    GDUFA IV Negotiation Session Minutes

    The ongoing GDUFA IV negotiations have shed some light on interesting...
    Read More
    March 2026 Mid-month Generic Approval Actions and Some Pet Peeve Commentary

    March 2026 Mid-month Generic Approval Actions and Some Pet Peeve Commentary

    Through March 16, the Office of Generic Drugs has issued 30 full appro...
    Read More
    FDA Q&A Guidance for Endotoxin and Pyrogen Testing Arrived Yesterday

    FDA Q&A Guidance for Endotoxin and Pyrogen Testing Arrived Yesterday

    While endotoxin and pyrogen testing might not be the sexiest of topics...
    Read More
    ADVANCE CONFIDENTLY
    Contact Us Today