FAQs
Working With Landrich Group

Q23: Does Landrich Group work with early-stage startups or only established companies?

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Landrich Group works with companies at all stages. In the past year, we’ve supported seed-stage startups designing their regulatory strategy before their first clinical study as well as the world’s largest publicly traded diagnostics companies managing post-market obligations and preparing for FDA inspections.

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For early-stage companies, we typically provide the most value in two areas: regulatory pathway assessment (helping founders understand which FDA pathway applies, what evidence is required, and how long it will take before they commit to a clinical development plan) and design controls consulting (helping teams build a design history file process from the start rather than retrofitting one before submission).

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Starting the regulatory conversation early, before studies are designed and before the DHF is built, consistently produces better submission outcomes than engaging a regulatory consultant when the submission is already late. If you're building an IVD or CDx program and haven't yet engaged regulatory expertise, the right time is now

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