TOXPLUS Monitoring
TOXPLUS (founded January 2020) provides nonclinical drug development support for biotechnology and pharmaceutical companies. Services focus on toxicology and pharmacology support, nonclinical study management and monitoring (GLP and non-GLP), vendor audits, data review/QC, and regulatory writing for submissions such as IND/NDA nonclinical sections. The company offers global monitoring coverage and customized program support across small molecules, large molecules, and cell & gene therapy programs.
Industries
Nr. of Employees
small (1-50)
TOXPLUS Monitoring
Chicago, Illinois, United States, North America
Services
Customized study management including CRO selection, protocol support, milestone tracking, data review, and report review/editing.
On-site and remote monitoring of nonclinical study conduct and data collection with configurable monitoring plans and regional coverage.
On-site or paper-based audits and qualification services for GLP and non-GLP CROs to assess compliance and study quality.
Toxicologist-led services including lead candidate selection support, study design input, data interpretation, program strategy, and participation in regulatory meetings.
Preparation and QC of regulatory documents including nonclinical sections of IND and NDA submissions, meeting packages, and tabulated summaries.
Customized study management including CRO selection, protocol support, milestone tracking, data review, and report review/editing.
On-site and remote monitoring of nonclinical study conduct and data collection with configurable monitoring plans and regional coverage.
On-site or paper-based audits and qualification services for GLP and non-GLP CROs to assess compliance and study quality.
Toxicologist-led services including lead candidate selection support, study design input, data interpretation, program strategy, and participation in regulatory meetings.
Preparation and QC of regulatory documents including nonclinical sections of IND and NDA submissions, meeting packages, and tabulated summaries.
Expertise Areas
- Nonclinical study management
- Nonclinical study monitoring
- Toxicology and pharmacology support
- Regulatory writing for IND/NDA nonclinical sections
Key Technologies
- Good Laboratory Practice (GLP) compliance and oversight
- Nonclinical study monitoring methodologies
- Regulatory submission authoring (IND/NDA nonclinical modules)
- CRO selection and vendor audit methodologies