FAQs
Working With Landrich Group

Q22: What makes Landrich Group different from other regulatory consulting firms?

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Landrich Group has maintained a 100% FDA clearance and approval rate across 19 regulatory submissions, with zero FDA 483 observations and zero warning letters across all client engagements. For IVD and device companies where a failed submission or a 483 observation can cost a year of development time and millions in rework, that track record matters.

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Beyond the outcomes, the differentiation is in how we work. Landrich consultants have direct experience as FDA reviewers and industry quality leads. We understand how FDA evaluates submissions from the inside. 

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We're also a genuinely global practice: our clinical and regulatory experience spans six continents. During the past year, we’ve worked onsite with clients in China, Belgium, Germany, and the Netherlands. This means we can support U.S. submissions for international manufacturers and design clinical studies that work across multiple regulatory jurisdictions. Landrich is deliberately boutique. Every client engagement involves senior consultants, not junior staff.

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