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Our Company

Founded in 2006 by Dr. Kimberly Brown, Amethyst Technologies provides quality program development and comprehensive technical assistance for global health, clinical diagnostics, analytical testing, research, and pharmaceutical manufacturing. Core services include quality systems development, auditing and assessments for compliance, clinical diagnostics and analytical testing programs strengthening, training, standard operating procedures development, laboratory operations management, and validation. Our team are experts in compliance with FDA, ISO, USP, and EU regulations.

Our Mission

We aim to improve health outcomes by providing “rock-solid” services and technical assistance for improved clinical diagnostics, translational research, compliant and convenient healthcare facilities and laboratories, and quality assured pharmaceutical manufacturing

Our Commitment to Quality and
Customer Satisfaction

Amethyst in Action: Delivering quality services for global health and standards creation In Challenging Environments

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Cancer Diagnostics - Government of Kenya

Contracted by Bomet County government to develop partnerships with US Cancer Centers
Assessed quality of diagnostics in Bomet County hospitals.
Developed a plan for a comprehensive cancer diagnostic center (design, capacity building).
Implementing an esophageal cancer study with Johns Hopkins Sidney Kimmel Cancer Center.

Amethyst’s INNOVATE Center of Laboratory Excellence in Ghana, Opening soon

ICOLE is a 6,000-square foot state-ofthe-art laboratory owned by Amethyst that will provide services for health, agriculture, water and sanitation, mining, and manufacturing sectors including technical assistance, training, a biorepository, and laboratories for contract research and manufacturing

Microbiology Lab
cGMP Cleanrooms
Chemistry Lab
Quality Control Lab

Biorepository
Training Center (eLearning)
Office Space

A Quality Management System for US Army Laboratories

Created a quality management system and 2,000 standard operating procedures.
Training programs for personnel that covered quality assurance, change control, test methods, maintenance, and documentation
Performed validation and calibration for equipment in BSL-2, BSL-3, and BSL-4 labs.
Developed, implemented, and managed the transition for new labs. User requirements were managed and communicated to vendors.
New equipment procurement.
Cold chain management of temperature sensitive materials.

US Army Tanzania Malaria and HIV Support Contract

Malaria Research Program Support including facilitation of collection and testing of samples, training, quality assurance, supply chain management strengthening, assessments, and laboratory certification.
Technical assistance and support for an HIV Behavioral and Biological Surveillance Study
Conducting Data Quality Assurance and SIMS

JFK Hospital Liberia and National Public Health Reference Lab

Training for hospital staff on safety, Ebola outbreak best practices, disinfection, waste
Training on sample collection and handling, diagnostics, and recordkeeping

PEPFAR Quality Improvement (QI) in Tanzania for USAID

Mentoring and Coaching on quality assured HIV testing country wide.
Improving patients' stability categorization in compliance with new HIV guidelines through training, procedures, assessments
Quality Improvement Package development and mentoring focused on improved retention of HIV clients and increased utilization of viral load data by clinicians.

PEPFAR Laboratory Strengthening in Kenya USAID HSDSA

Quality Improvement for HIV diagnostics in 10 counties (50,000 HIV patients)
Management and procurement of maintenance of critical equipment
Biosafety training and waste management
Performing SIMS assessments
Strengthening the use of viral load data for decision making
Supporting External Quality Assurance (EQA)

Equipment Validation for FDA Compliance- NIH

Performing temperature mapping, calibration, and validation services for equipment.

US Army Medications Procurement in Ghana

Annual procurement of medications for training healthcare professionals in Ghana at reduced rates and short timeframes.

Quality Control for ISO 15189 HIV Diagnostics

Provided quality control mentors for hospitals in Tanzania to provide training on lab management, HIV diagnostics, safety, maintenance, supply chain, and records
Performed emergency on-call HIV testing.

Assessments of Hospitals for Quality Assurance and Compliance in Iraq -Department of State

Developed plans for assessing hospital biomedical equipment programs.
Performed Independent Verification and Validation for hospitals in Iraq to determine the adherence to Joint Commission, FDA
Developed detailed reports on the results of assessments and recommendations for strengthening maintenance programs.

Annual procurement of medications for training healthcare professionals in Ghana at reduced rates and short timeframes.

PEPFAR Site Improvement through Monitoring System (SIMS) Assessments in Tanzania

USAID Tanzania partner implementing SIMS assessments at above sites, health facilities, and community sites as Prime Contractor.
Performing data collection and analysis of quality indicators for HIV programs.
Providing gap analyses feedback to organizations and stakeholders on methods for performance improvement.
Development of the work plan and logistic plan and performing all logistics to travel and assess sites within budget and on schedule.

US Army Tanzania Malaria Research Program Management

Developed quality assurance procedures tailored specifically for the remote labs in Tanzania that covered materials, equipment, labeling, storage, waste, safety, and quality control for performing malaria diagnostics
Performed 400 comprehensive assessments.
Facilitated training courses on malaria diagnostics and WHO certification. Results? Reduced false positives; quality control improved; reagent costs reduced 25%.

Kimberly Brown, President and CEO

Kimberly Brown PhD, founder and CEO of Amethyst Technologies, began working in the biotechnology compliance industry in 1998 as an intern for Cell Systems, Inc. while pursuing her doctorate degree. At the time, the company had one employee, the owner, and provided services to Walter Reed’s Pilot Bioproduction Facility (WRAIR PBF). After completing her studies, Dr. Brown continued to work for Cell Systems as validation manager for WRAIR PBF and as Cell Systems’ operations manager.

She increased the project scope at WRAIR PBF to include quality system development, custom software to support FDA-regulated activities, and the validation master plan to ensure sterile vaccines,

increasing the contract with the addition of validation services, managing the environmental monitoring system, and commissioning for clean rooms and utilities.

Dr. Brown purchased the contract rights from Cell Systems, Inc. in February 2007, and received the contract to continue providing services to WRAIR PBF. Since then, Amethyst Technologies has experienced steady growth in employees, client base, and revenues. Under her guidance, Amethyst Technologies has grown from two employees to more than 40. Amethyst is a prime contractor to the US Army, USAID, NIH, FDA, Department of State, and the CDC. Amethyst operates in the US, Africa, and Middle East.

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