GLP/GCP Quality Assurance, Scientific Support & GLP/GCP Archiving SolutionsQuality Assurance Consultancy offers a complete array of regulatory consulting solutions to universities and companies in the pharmaceutical and agrochemical industries. Since 1986, quality assurance (QA) has been the cornerstone of our offerings, from Good Practice (GLP)/Good Clinical Practice (GCP) QA to Scientific Support and Archiving. Together with our team of specialized and experienced scientific consultants, we can help you reduce the time and expense of meeting critical internal and regulatory requirements.
GLP/GCP Quality Assurance SolutionsQuality Assurance Consultancy provides contract QA solutions under the following Code of Federal Regulations (CFRs) and more:
- 21 CFR Part 58. Food and Drug Administration (FDA) GLP for Non-clinical Studies
- 40 CFR Part 160. Environmental Protection Agency (EPA) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) GLP Standards
- 40 CFR Part 792. EPA Toxic Substances Control Act (TSCA) GLP Standards
- Organisation for Economic Co-operation and Development (OECD) Series on Principles of GLP
- FDA GCP regulations and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidance
Scientific Support SolutionsQuality Assurance Consultancy provides scientific support for conducting studies in the registration of pesticide products. Our experienced scientists can help you when your internal resources require greater study oversight. Operating as study directors, study monitors or principal investigators, we can support your efforts in:
- Designing, writing and evaluating protocols
- Fulfilling study monitor/director responsibilities
- Conducting technical data and report reviews
- Preparing study reports
- Executing submission reviews
- Preparing report summaries, electronic submissions and rebuttals
- Identifying and qualifying contractors
GLP/GCP Archiving SolutionsFor more than 25 years, Quality Assurance Consultancy has supported private and public organizations with an unmatched team of experienced, expert professionals and an array of GLP/GCP Archiving Solutions, including our premier archive facility with its temperature and humidity controls for safely and securely storing documents, specimens and electronic media.
Visit our Information Systems Division website.