TESTIMONIALS
"I worked closely with the Landrich Group to strengthen Clinical Operations at Roche Diagnostics, particularly within our inspection readiness program for a few high-visibility, CRO-outsourced trials. Their deep clinical operational, quality, and regulatory expertise—combined with their ability to rapidly understand the nuances of complex diagnostic and device trials—made a significant impact on our organization.
Landrich’s mock audit process was exceptionally thorough, practical, and solution-oriented. Their team provided clear, actionable guidance that not only strengthened our documentation and vendor oversight practices but also elevated our internal teams’ confidence ahead of health authority inspections. Their proactive insights helped us identify risks early, streamline cross-functional alignment, and reinforce a culture of inspection readiness across multiple programs.
We especially valued their responsiveness, clarity, and ability to partner seamlessly with both internal teams and CRO counterparts. Thanks to their disciplined approach and strategic recommendations, we improved operational quality, reduced inspection-related risks, and enhanced our overall state of compliance.
I highly recommend the Landrich Group for any organization seeking expert support across clinical operations, vendor oversight, quality systems, and regulatory preparedness."
Hal Mann, MBA
Former Sr. Director, Clinical Operations at Roche Diagnostics
"I had the privilege of working with the Landrich group on miDiagnostics’ IVD test for HSV-1&2. Their support and expertise in quality, clinical, and regulatory affairs, along with their extensive network, were instrumental in the successful clinical validation of our product. Our successful collaboration culminated in product clearance just nine months after submission. I highly recommend working with the Landrich Group on your projects."
Vesna Kostanjevecki
VP of Clinical, Assay & Regulatory Affairs at miDiagnostics
"Tina came very highly recommended to us at a time when we were looking for someone to help us navigate the regulatory requirements on investigational devices, support us in the preparation of a GCP compliant documentation system as a Sponsor and Investigational Site and submit our own clinical study protocol with an independent IRB. No one in the company had prior experience in navigating any of this!
Tina was fantastic – she was very practical in establishing the regulatory requirements that our company was obligated to. She was also very flexible in helping us adapt a process for the preparation and review of our documentation while staying within our budget. She has tremendous attention to detail, a very high work ethic, and incredible dedication to assisting you achieve your goals. She also has a very talented staff augmenting her expertise to provide a well-rounded team for your clinical project."
Kalavati Bhashyam
Former Vice President of Products at Harmonic Bionics, Inc.
"It has been a pleasure to work with Tina and the Landrich Group on a number of clinical trial projects over the past 10 years. Tina is a conscientious, highly experienced clinical development professional with a strong sense of process and detail as well as schedule and priorities.
Recently she led our effort to conduct multiple clinical trials for an FDA submission at multiple US sites for a multiplex rapid POC test. She managed the project effectively and maintained excellent rapport with the clinical investigators and lab personnel. When we needed to hit a tight deadline for completing reports, she rallied to the objective and made it happen."
David Ludvigson
President & CEO at Nanomix, Inc.
"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."
Salvador Rico, MD, PhD
Chief Medical Officer at Encoded Therapeutics