OUR SPECIALTIES
Landrich Group specializes in advancing In Vitro Diagnostics, Medical Devices,
Companion Diagnostics, Clinical Quality Assurance, and Biopharma through
Clinical Research, Quality, and Regulatory consulting services.
In Vitro
Diagnostics
Medical Devices
Biopharma
OUR SERVICES

FAQs
FDA Submission & Regulatory Pathway
Inspection Readiness & Quality Systems
How do I prepare for an FDA inspection as an IVD manufacturer?
What is a Design History File and what does FDA expect to see in it?
What changed under QMSR and does our ISO 13485 certification still satisfy FDA?
What are the most common causes of FDA 483 observations for IVD companies?
What is a mock FDA audit and when should we schedule one?
Companion Diagnostics & Biomarker Strategy
What is a companion diagnostic and how is it regulated by the FDA?
How does FDA CDx regulation differ from EU IVDR requirements for companion diagnostics?
What clinical evidence does FDA require to approve a companion diagnostic?
What is the difference between a companion diagnostic and a complementary diagnostic?
How do we manage parallel FDA and EU submissions for a companion diagnostic?
International & Foreign Manufacturer
Do foreign medical device manufacturers need a U.S. Agent to sell devices in the United States?
How does a U.S. Agent work with the FDA?
Can our U.S. distributor serve as our FDA U.S. Agent?
What do international IVD manufacturers need to know before submitting to FDA?
Does Landrich Group serve clients outside the United States?
Working With Landrich Group
Have a question not answered here?
Contact the Landrich team to discuss your regulatory situation.
OUR INDUSTRY EXPERIENCE AND PROGRAMS SUPPORTED BY LANDRICH GROUP
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The Landrich Group has conducted trials in 6 / 7 continents as of 2026.









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