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Clinical Research, Quality and Regulatory Consulting Services

Established CRO with Clinical, Quality and Regulatory consulting services and solutions for In Vitro Diagnostics, MedTech, and Biotech, helping you bring innovative healthcare products to market.

OUR SPECIALISTS

Landrich Group specializes in advancing In Vitro Diagnostics, Companion Diagnostics, Precision Medicine, Medtech, and Biopharma through expert regulatory strategy and clinical research support.

In Vitro
Diagnostics

Companion
Diagnostics

Precision Medicine

Medtech

Biopharma

OUR SERVICES

Scientist using microscope

QUALITY ASSURANCE

Offering QMS gap assessments, FDA, EU, and other regional inspection readiness support.

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Spilled prescription pills

U.S. AGENT

Serving as the official U.S. Agent for foreign pharmaceutical and biotech companies to meet FDA requirements.

 

Scientist in laboratory

CLINICAL SERVICES (CRO)

Providing end-to-end clinical trial management, from study design to regulatory submissions, ensuring compliance and efficiency.

Laboratory

R&D SUPPORT

Supporting research and development with strategic consulting, laboratory services, and technical expertise.

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Experts Panel

REGULATORY AFFAIRS

Expert FDA and global regulatory support, including Reg Strategies, FDA Pre-Subs, IDE, IND, 510(k), PMA, BLA, & NDAs.

Lab analysis on computer

BIOSTATISTICS

Offering advanced statistical analysis and data interpretation to support clinical trials and scientific research.

 

MEET THE FOUNDER

Tina Landess

Proudly serving our clients clinical research needs for over 20 years.

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Dave Petrich

Proudly serving our clients clinical research needs for over 20 years.

Salvador Rico, MD, PhD

Chief Medical Officer at Encoded Therapeutics

"Tina is an exceptional clinical operations professional, with unique expertise in GCP compliance and inspection readiness. Thanks to her efforts we were ready to face multiple BIMO inspections that contributed to two PMA approvals. Subsequently, Tina built a high functioning clinical operations team that successfully conducted multiple phase 1-4 clinical trials with three different products.

 

Along the process, she also designed and built the infrastructure to support and coordinate all the workload while meeting industry and regulatory standards."

ARTICLES

  • What services does Landrich Group offer?
    Landrich Group provides comprehensive services in the life sciences industry, including clinical trial management (CRO), Quality Regulatory Affairs support for FDA and global compliance, and GCP/GMP training to ensure adherence to industry standards. We also serve as a U.S. Agent for foreign companies navigating FDA regulations, offer R&D support through strategic consulting and technical expertise, and provide biostatistical analysis to support clinical trials and scientific research. Our expertise helps clients streamline operations, maintain compliance, and accelerate innovation in healthcare and biotechnology.
  • Can Landrich Group assist with clinical study management?
    Yes, Landrich Group provides comprehensive clinical study management services as a Contract Research Organization (CRO). Our team supports every stage of the clinical trial process, including study design, regulatory submissions, site selection, patient recruitment, data management, and compliance with GCP guidelines. We work closely with sponsors to ensure efficient trial execution, regulatory adherence, and high-quality results to support drug and medical device development.
  • Does Landrich Group offer training services?
    Yes, Landrich Group offers comprehensive training services, including specialized programs in Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). These training sessions are designed to help professionals stay current with industry standards and regulatory requirements, ensuring that teams are well-prepared for compliance and quality assurance in clinical studies and manufacturing processes.
  • Does Landrich Group work with startups or only large companies?
    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.

CLINICAL STUDIES & GLOBAL SUPPORT EXPERT

The Landrich Group has conducted trials in 6 / 7 continents as of 2025.

LANDRICH GROUP

Clinical, Quality, and Regulatory consulting services to Medical Devices, IVD, and Pharmaceutical clients.

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CONTACT

2532 Santa Clara Ave Suite 344, Alameda, CA 94501

+1 510 912 2589

@ Since 2017 Landrich Group - All rights reserved.

Contact us

For any questions you have, you can reach us here:

Tina Landess

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2532 Santa Clara Ave, Suite 344

Alameda, CA 94501

United States

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admin@landrichgroup.com

+1 510.912.2589

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© 2025 by Landrich Group 

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