Lachman Consultants

Lachman Consultants is a long-established, privately-held US consulting firm serving the highly regulated life sciences sector. It differentiates itself through a deep bench of former FDA regulators and subject matter experts who provide hands-on guidance for regulatory submissions, quality system compliance, and inspection readiness. The company operates globally, with a focus on pharmaceuticals, biologics (including advanced therapies), and medical devices, generating revenue through its expert advisory services. Its model is built on mitigating regulatory risk for clients aiming to bring products to market in the US, EU, and other key regions.

Intellectual capital and proprietary methodologies based on deep regulatory experience, including a team of former senior FDA officials and industry experts. Service delivery is systematized through protocols for mock audits, regulatory strategy, submission preparation, and compliance remediation.

Lachman competes in a fragmented market including large multinational professional service firms (e.g., Deloitte, PwC), specialized regulatory/quality consultancies, and individual solo practitioners. Its differentiation is its long-standing reputation and deep bench of former FDA insiders, which provides a high level of credibility and practical insight for complex compliance and submission challenges.