With expertise in pharmacology, toxicology and medical writing, ToxPlus Consulting is your partner in developing preclinical study programs including preclinical study protocol development, study placement, study monitoring, reviewing and summarizing both GLP and non-GLP pre-clinical toxicology and safety pharmacology studies.
In addition, we have project management, medical writing and document preparation capabilities. We represent companies and associations during regulatory meetings with agencies and at various scientific venues.
We look forward to working with you!
Medical Device Testing
Safety assessments of extractables and leachables.
Safety data sheet preparation.
Hazard band determination
Expert presentations on various scientific and regulatory topics including:
-Regulatory landscape of the IND, NDA process
-Various toxicology topics
Prepare and manage scientific manuscript preparation and submission.
Pre-Clinical toxicology and pharmacology sections (written summaries and tabulated summaries) of INDs and NDAs
Pre-clinical toxicology and pharmacology sections (written summaries and tabulated summaries) of INDs and NDAs
Pre-IND meeting information packages
Fast Track Applications
Orphan Drug Applications
Safety assessments of APIs, excipients, impurities, and extractables/leachables
Other regulatory documents
Pre-IND enabling study design and study management services.
ToxPlus Consulting has expertise in medical/technical writing to meet the needs of clinents.
ToxPlus Consulting provides expertise in global regulations, preparation of regulatory documents and regulatory strategy to meet our clients' goals.
Pre-Clincial Toxicology and Safety Pharmacology testing strategy development and program management.
ToxPlus Consulting provides toxicology expertise spanning small molecule drugs, biologics, vaccines and biosimilars. We work to develop the best approach to meet the clients' needs.
ToxPlus Consulting provides clients with literature reviews, literature monitoring reports and white papers.
Assistance with selecting animal models and selecting CROs who can conduct studies with select animal model.
Editorial services and writing services available. Quotes upon request.
Pharmacology/Toxicology expert in data interpretation and study design for discovery or pre-clinical studies. Also, services include scientific writing in the area of pharmacology/toxicology.
Scientific Manuscript editing services. Quotes upon request.
GLP Audit and Study Monitoring Services
-GLP Study Monitoring
Product Development, Testing, and Packaging Services
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