FAQs
Working With Landrich Group

Q21: What types of companies does Landrich Group work with?

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Landrich Group works primarily with in vitro diagnostic (IVD) companies, medical device manufacturers, and biopharma organizations at various stages of product development. We’ve supported a range of organizations, from early-stage startups designing their first IVD to established companies preparing for FDA inspection or navigating post-market obligations.

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Our core client base includes IVD and CDx developers seeking FDA 510(k) clearance or Premarket Approval; medical device companies preparing for FDA or international inspections; foreign manufacturers entering the U.S. market for the first time; and pharmaceutical companies developing companion diagnostics in relation to therapeutic programs.

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We also support contract research organizations (CROs) and clinical trial sites with quality assurance and ICH E6(R3) compliance programs, and we work with companies pursuing ISO 9001 or ISO 13485 certification as a foundation for regulatory compliance. If your organization is navigating FDA regulatory requirements for a device or diagnostic, we are likely a fit.

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