FAQs

Landrich Group is a specialized consulting firm based in Alameda, California, with a strong global presence and a proven track record of success across international markets. We offer expert clinical, regulatory, and quality services to clients in the medical device, in vitro diagnostics (IVD), and pharmaceutical industries. Our team supports the full product development life cycle—from early design and development through clinical trials, regulatory submissions, global clearances (including FDA, EU, and other international authorities), approvals, and post-market activities.

Landrich Group provides a wide range of expert consulting services to support medical device, IVD, and pharmaceutical companies throughout the entire product lifecycle. With a strong global presence, we assist clients navigating complex regulatory and clinical environments in the U.S., EU, and other international markets. Our core capabilities include:

• Clinical Services (CRO) – Full-service clinical trial management and monitoring.

• Quality Assurance – Offering QMS gap assessments, QMS implementation, FDA, EU and other region inspection readiness support.

• Regulatory Affairs – Strategic regulatory guidance including FDA, EU MDR/IVDR, and international submissions etc., pre-sub meetings, submissions, and post-market support.

• Quality Management Systems – Design, implementation, and auditing of QMS.

• Data Management – Clinical data handling, validation, and reporting across multiple regulatory jurisdictions.

• U.S. Agent Services – Acting as U.S. Agent for foreign (ex-US) manufacturers to coordinate communications with the FDA to ensure regulatory compliance. For non-U.S. companies, the FDA requires the designation of a U.S. Agent—and we're here to fulfill that role with clarity and confidence.

• GCP/GMP Training – Custom training programs on Good Clinical/Manufacturing Practices.

• SOP Development – Develop and optimization of Standard Operating Procedures to meet global compliance requirements.

• R&D Support – Technical, quality and regulatory assistance for analytical and clinical performance evaluation studies during product development.

• Biostatistics – Statistical planning, analysis, and reporting for clinical studies.

We tailor our services to meet your specific needs, from early-stage development to post-market support, across U.S. and international markets.

We serve a broad range of companies, from startups to established global multinational corporations in the medical device, diagnostics, and pharmaceutical industries. Our clients often seek support during critical milestones such as regulatory submissions, clinical trials design, planning and execution, or QMS inspections.

Landrich Group stands out for its deep industry expertise, highly personalized approach, and proven track record of successful product development and regulatory clearance—both in the U.S. and globally. Our team brings decades of hands-on experience and works as a true extension of your internal team, customizing solutions to fit your goals across global markets and regulatory landscapes.

Since 2016, we have maintained a 100% success rate across 20 programs and 19 regulatory submissions, including 510(k)s, Emergency Use Authorizations (EUAs), and clinical evaluations in infectious diseases, oncology, and diagnostics. Our results include:

• 0% Warning Letters

• 0% FDA 483 findings

• 100% success in areas such as Usability, Reproducibility, Reference Range, and QMS inspections

These metrics reflect our unwavering commitment to quality, compliance, and client success.

Yes, Landrich Group provides full support for FDA pre-submission meetings, IDEs, 510(k)s, De Novo 510(k)s, PMAs, EU IVDR and MDR Technical File Dossiers. We also help interpret feedback from the FDA and other National Competent Authorities to and adjust your clinical or regulatory strategy accordingly.

Absolutely. In addition to U.S. regulatory expertise, we assist clients with CE marking under the EU MDR/IVDR, as well as with global clinical trials and international market access strategies. The Landrich Group has performed clinical trials in 6 of 7 continents and is currently managing Companion Diagnostics (CDx) studies in China.

Yes, we offer a full range of Good Clinical Practice (GCP), Good Documentation Practices (GDP), and Good Manufacturing Practice (GMP). The Landrich Group also offers training for other relevant topics like Design Control, Risk Management, and Usability Engineering.

The Landrich Group specializes in CDx studies and has supported the following therapeutic areas:

• Ophthalmology

• Dermatology

• Hematology

• Transfusion Medicine

• Cardiology

• Oncology

• Infectious Disease

• Digital Health

We offer both. Depending on client needs and project scope, our consultants can work on-site or remotely. Our team is highly flexible and able to integrate seamlessly with your operations.

Yes, the Landrich Group, as an experienced CRO, can support all phases of clinical study management from developing clinical plans, protocols, managing clinical trials, preparing regulatory submissions, etc.

Landrich Group works with companies of all sizes, from startups to large enterprises. We provide tailored solutions to meet the unique needs of emerging biotech and pharmaceutical startups, as well as established organizations. Our team offers strategic guidance, regulatory support, clinical trial management, and training services to help startups navigate complex industry regulations and accelerate growth, while also supporting large companies with scalable and efficient solutions.

Simply contact us via our Contact page or email us at admin@landrichgroup.com. We will schedule a free of charge initial consultation to understand your needs and recommend a tailored statement of work for your project.