They do not typically include projects of a discovery, or exploratory nature (e.g., target identification, high throughput screening, early efficacy models, early safety studies).
Some of the project types that would require GxP services include:
- Agricultural or environmental toxicology studies or study phases under EPA GLP regulations, or equivalent (for non-U.S.)
- Pivotal Nonclinical Drug Safety Studies or study phases under FDA GLP regulations, or equivalent (for non-U.S.)
- Manufacturing, characterization or packaging of therapeutics (active pharmaceutical ingredients) for humans or companion animals under GMP guidance (ICH Q7) and/or FDA regulations (or equivalent for non-U.S.).
- Procurement or distribution of human-derived specimens or analysis of such specimens for exploratory purposes, e.g., biomarker identification, under certain requirements of GCP and patient/subject privacy laws (e.g., HIPAA), or for diagnostic purposes under federal certification (e.g., CLIA) or international accrediting programs (e.g., CAP).
- Human clinical trials and sample analyses required to be conducted under federal GCP and patient/subject privacy regulations.
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