Phoenix Laboratory Consulting provides concept-to-launch development and validation services for academic, clinical, software, technology, and pharmaceutical industry clients.
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? Clinical Research/Regulatory
Developed and managed the Quality System at PGXL Laboratories to support development of a Class II software-based medical device for genotype-guided warfarin dosing
o Wrote all Quality System SOPs
o Validated, implemented, and managed the MasterControl DHF document management system
o Compiled, organized, and wrote the software...
Aug 10, 2011|Grant Writing|$87|Completed
Phoenix Laboratory Consulting is owned and managed by Bronwyn Ramey-Hartung, PhD, out of a private office near Louisville, KY. Dr. Ramey has more than 15 years of laboratory experience in academic and clinical laboratories.
PLC has specialty experience in the biological and medical sciences, including microbiology, genetics, molecular genetics, molecular cloning, biochemistry, pathogenesis, plant biology, molecular diagnostics, pharmacogenetics, and technical assays.
PLC is particularly focused on molecular pharmacogenetics assay design, validation, and troubleshooting of DNA isolation, robotics, QuantStudio, TaqMan, Luminex, and RFLP technology. Specialties include CYP450 haplotyping and copy number analysis.
PLC also develops regulatory strategies for software-based decision support tools, including quality systems, electronic records, and IVDs. We have a deep understanding of FDA requirements and ISO standards for medical devices and laboratories.
Recent uncertainty in the regulatory environment surrounding laboratory-developed tests and FDAs changing perspective on their role in regulating such tests has presented a particular challenge to clinical laboratories. PLC will help you develop, implement, and maintain best-practice strategies to exceed the requirements of CLIA 88 and prepare for stricter oversight.
PLC understands and can interpret current regulations surrounding the development and marketing of laboratory tests and is monitoring the changing...
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Pharmacogenetics Diagnostic Laboratories, LLC
Manager of Technology Development
2006 - Present
Supervise the design and implementation of new clinical molecular diagnostic assays for the clinical testing menu.
Supervise the implementation and maintenance of quality systems for 21 CFR 820...