LANDRICH GROUP
Our Mission
​
​
At Landrich Group, our mission is to provide ‘best in class’ Clinical, Quality and Regulatory consulting services to our medical devices, IVD and pharmaceutical clients. ​
​
The Landrich Group provides a broad range of customized solutions to fit our clients needs across every stage of their company’s development including design & development, analytical & clinical performance evaluations, manufacturing and post-market support.
Meet The Founder
Serving our clients clinical research needs for over 20 years
An experienced, self-motivated, quality-focused clinical project leader with over 20 years of clinical research management and monitoring experience. Working effectively to manage clinical activities for Pharmaceutical, Medical Device & In vitro Diagnostic Manufacturers. Experience in multiple therapeutic areas such as Ophthalmology, Dermatology, Hematology, Transfusion Medicine, Companion Diagnostics, Cardiology, Oncology, Infectious Disease, & Diabetes. Proven track record of well-managed clinical studies resulting in successful inspections and regulatory approvals.
​
Tina loves to read, take sewing classes with her friends, and in her spare time she volunteers her time and talents to her favorite charity and scientific organizations.
Tina Landess
Meet Our Team
Our Services
Biostatistics
Data Management
Clinical Services(CRO)
U.S. Agent
SOP Development
Regulatory Affairs
GCP/GMP Training
Our Industry Experience and programs supported
by Landrich Group
Extensive experience managing clinical studies and supporting clients across the globe
_edited.png)
_edited.png){kind=small}
Sponsor
Regions
Site
The Landrich Group has conducted trials in 6 / 7 continents as of 2024
News
LDT Regulation in US and EU: Similarities and Differences
​
Laboratory Developed Tests (LDTs) play a key role in global healthcare, allowing health institutions to develop specific diagnostic tools that are not mass-produced or commercially available. During the COVID-19 pandemic, they received spotlight attention with an unprecedented demand for decentralized, rapid diagnostic tools. They play a vital role in many emerging trends, such as personalized medicine, gene expression profiling, and pharmacogenomics...
Understanding Companion Diagnostics Regulation in the U.S. and EU
​
Regulatory authorities in the United States (US) and the European Union (EU) are responding to the growing role of Companion Diagnostics (CDx) for innovative therapies. These authorities differ in tactical implementation of regulatory coordination and approval....
Microbio conducts commercial evaluation trials in Ecuador
​
Australian biotech scale-up Microbio has started commercial evaluation trials in Ecuador prior to launching its flagship InfectID-BSI (Bloodstream Infection) test in South America.
​