TOGETHER WE REACH YOUR GOALS
Angie Purvis, PhD
ANGIE PURVIS, LLC
REGULATORY
Regulatory solutions designed specifically for your company, product, and market. We craft dynamic strategies that adapt to the ever-evolving global marketplace and changing regulations. With our extensive expertise, we're here to tackle your complex regulatory needs with confidence and enthusiasm.
QUALITY SYSTEMS
Quality Management Systems built to meet your compliance needs and to streamline your business operations. We pride ourselves in building and implementing Quality Management Systems to scale to your company's needs and fit with your company's culture. We see you through every step of the way.
CAP/CLIA LABS & LDTs
We specialize in helping clinical diagnostic laboratories with laboratory developed tests (LDT) to achieve certification under CLIA regulations in all 50 States and to achieve timely compliance with the LDT Rule. We lead regulatory strategies for FDA clearance/approval for LDTs. We support CLIA laboratory build efforts from the point of site selection, assay validations, regulatory inspections, and launch. Our Principal is a licensed Laboratory Director for high-complexity testing and LDTs (CAP/CLIA & New York).