Expertise. Diligence. Resilience.These three attributes are the hallmarks of Quality Assurance Consultancy. With unparalleled talent and industry knowledge, we create greater value at every touch point of the quality assurance (QA) lifecycle.
- Our team of full-time, QA professionals have proven track records as practicing scientists in regulated industries and know how to conduct QA functions under the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) GLP and GCP principles.
- Our auditors possess strong scientific and regulatory experience, which allows them to evaluate and create quality programs to meet the challenges of today’s regulatory environment facing our clients.
- Our dedicated experts have established more than 50 GLP programs for new and established companies in the pharmaceutical, agrochemical industries and more—providing full support in program implementation and maintenance.
Comprehensive Services:Quality Assurance Consultancy provides full coverage or customized support for all aspects of your company’s QA needs, including the highlights below:
Auditing: We can meet any of your auditing needs from study protocol, in-phase, data and report audits, as well as Contract Research Organization (CRO) facility qualification audits.
Training: Our specialists conduct introductory, refresher, as well as advanced GLP seminars for technical staff and QA professionals.
GLP/GCP Archive Services: We maintain fully compliant GLP/GCP archive facilities for storage of documents and specimens, as well as secure retention of samples, etc.
Technical Support: We provide technical support services for Standard Operating Procedure (SOP) preparation, data form preparation, protocol development, etc.
Staff Augmentation: We can fill an array of specialized positions, such as study monitor, sponsor representative, data management, report writing and more.