Regulatory Compliance Consulting
Maintaining Regulatory Compliance is Paramount
Failing to comply with regulatory requirements is costly and most often not intentional, which is why we offer compliance consulting services to ensure that your lab operates within the law. Our regulatory compliance consulting helps our clients avoid making costly mistakes and ensures they remain in compliance.
Here’s How We Can Help:
Our team of industry experts for our regulatory compliance services has guided hundreds of labs successfully through this complex process and can do the same for you. We offer:
1. Regulatory consulting on the application process for CLIA licensure, CAP, and COLA accreditation requirements.
2. Knowledge of applicable state and federal laboratory quality requirements.
3. Experience interpreting state laboratory quality regulations and how they apply to your laboratory.
According to CLIA’s Last Top 10 Deficiencies Report:
Labs had Specimen Storage Deficiencies
Labs had Proficiency Test Deficiencies
Labs had Personnel Competency Assessment Deficiencies
Labs had SOP Deficiencies
Labs had Sample Labeling Deficiencies
Learn more about our Regulatory Consulting Services
Our Technical Consulting
Management Team
Our highly qualified team of scientific and regulatory experts will guide your laboratory throughout the process so you rest confidently knowing that your lab meets compliance standards.
Chief Quality Officer
Dr. Anna Hill, Ph.D., TC(NRCC)
Dr. Anna Hill provides support for the laboratory’s quality and compliance. She brings unmatched expertise in quality management.
Senior Quality Manager, Laboratory Director
Dr. Preeti Purwaha, Ph.D., TC(NRCC)
Dr. Preeti Purwaha has an extensive technical, compliance and managerial expertise in both research and clinical laboratories.
Quality Manager, Laboratory Director
Dr. Cierra N. Sharp, Ph.D., NRCC, DABCC
Dr. Sharp oversees proficiency testing for the laboratories and ensures that competency and training requirements are met for all testing personnel.
Quality Coordinator
Aaliyah Bristol
Liaison to clients for various laboratory application processing needs. Prepare & submit documentation for the CMS 116 CLIA and In State and Out of State licensures as applicable.
Dr. Anna Hill, Ph.D., TC(NRCC)
Chief Quality Officer
Dr. Anna Hill will provide support for the laboratory’s quality and compliance. Having overseen dozens of accreditation inspections (including the nation’s first accreditation of a laboratory under A2LA’s Platinum Choice Accreditation Program), Dr. Hill brings unmatched expertise in quality management.
She will oversee the generation of the lab’s standard operating procedures and offer guidance to ensure that all build-out efforts are conducted in compliance with the requirements of CLIA and other accreditation agencies.
Dr. Preeti Purwaha, Ph.D., TC(NRCC)
Senior Quality Manager, Laboratory Director
Dr. Preeti Purwaha implements quality and compliance protocols for new laboratories/accounts, monitors, reviews, and approves quality assurance and quality control metrics, performs customized SOP development for CLIA/CAP/COLA compliance, performs on-site laboratory audits to ensure quality and compliance, provides training and support for Quality programs for new personnel and leads and participates in CLIA, CAP, and COLA inspections. As a Laboratory Director and Supervisor, Dr. Purwaha manages operations and ensures Quality compliance at these labs. Being an excellent team player, Dr. Purwaha collaborates effectively with data analysis, laboratory personnel, and operations teams to carry out Quality related tasks and maintain a high-quality laboratory environment.
Dr. Purwaha is a Certified NRCC (HHS approved board) Toxicological Chemist (CLIA qualified High Complexity Clinical Laboratory Director), and Senior Quality Scientist with extensive technical and managerial expertise in both research and clinical laboratories. Dr. Purwaha has a Ph.D. in Pharmaceutical Sciences from North Dakota State University, Fargo, ND. Dr. Purwaha brings with her about 10 years of technical expertise in LC/MS based method development and validation methodologies for the analysis of small molecules, drugs, drug metabolites, and toxicological agents, and several years of experience in laboratory Quality Management. Dr. Purwaha has published several research articles in top-rated peer-reviewed journals and has been an invited speaker at several national conferences.
Dr. Cierra N. Sharp, Ph.D., NRCC, DABCC
Quality Manager, Laboratory Director
Dr. Sharp is board-certified in Clinical Chemistry by the National Registry of Certified Chemists (NRCC) and is a Diplomate of the American Board for Clinical Chemistry (ABCC). She received her Ph.D. in Pharmacology and Toxicology from the University of Louisville in 2018 and completed a Clinical Chemistry Fellowship at the same institution in July 2020.
Dr. Sharp will provide support for the laboratory’s quality and compliance. She will oversee proficiency testing for the laboratory and ensure that competency and training requirements are met for all testing personnel. Her focus is on improving quality in the lab and quality-related workflows for the company. She also serves as Laboratory Director for several laboratories.
Aaliyah Bristol
Quality Coordinator
Liaison to clients for various laboratory application processing needs. Prepare and submit pertinent documentation for the CMS 116 CLIA and In State and Out of State licensures as applicable.