TOXPLUS provides customized and comprehensive solutions to support nonclinical drug development. We work with your team to create a nonclinical drug development plan that is optimal for your drug development needs.
Study Management For Nonclinical Programs
TOXPLUS provides a customized approach to nonclinical study management. We work with your team to create a study management plan that is optimal for your drug development needs. Study management tasks can be customized and may include but are not limited to:
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CRO bidding and selection
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Management of CRO activities and protocol development
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Tracking program/study milestones and timelines
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Support with data review activities
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Support with study report review and editing
Regulatory Writing Support
TOXPLUS provides regulatory writing support ensuring clarity and compliance with regulatory requirements. Our expertise includes INTERACT meetings, pre-IND meetings, preparing nonclinical sections of IND and NDA Module 2.0 submissions for US FDA filings, complete with tabulated summaries as well as regulatory documents for other agencies. Additionally, we provide QC services for all regulatory documents.
All of our services can be customized to fit your drug development operation needs. Please contact us to schedule a meeting to discuss how we may support your program.
Vendor Audits And Qualifications
TOXPLUS provides on-site or paper based nonclinical vendor audit services for both non-GLP and GLP CROs. Vendor audits identify that expectations are being met and that quality studies are conducted. Vendor audits can maximize confidence and help your company make informed decisions regarding placement of nonclinical studies.
Toxicology Support
TOXPLUS toxicology support services include every stage of the process from lead candidate selection to market approval including gap analysis, program strategy development, CRO selection, study designs and data interpretation.
We also participate in client and regulatory meetings as needed, ensuring compliance and strategic alignment. A toxicologist is available on a customized basis to support your nonclinical drug development programs.
Additional services include report writing and specialized regulatory writing projects such as regulatory waivers.
TOXPLUS has a global team of study monitors ready to support your program when and where you need them. TOXPLUS offers study monitoring support in North America, Asia, and Europe. We support your studies with oversight of study conduct and data collections when you cannot be there and can customize a study monitoring plan to fit your exact program needs. Our team has nonclinical study monitoring expertise in the development of small and large molecules, additionally in cell and gene therapy studies.
