TOXICOLOGYToxPlus Consulting provides toxicology expertise spanning small molecules, biologics, and gene therapies.  We work to develop the best approach to meet the clients' needs.       Pre-Clinical IND-enabling study strategy Pre-Clinical toxicology and safety pharmacology study management Study identification and protocol designLaboratory proposal management and assistance with laboratory selection including site visitsOn-site study monitoring Study data interpretation and study report reviewParticipation in meetings with regulatory authoritiesData Gap AnalysisSafety assessments of excipients, impurities, extractable and leachablesSDS development and hazard banding determinations   REGULATORY AFFAIRSToxPlus Consulting provides expertise in global regulations, preparation of regulatory documents and developmental strategy to meet our clients' goals. Non-clinical sections of INDs/NDAs in legacy and eCTD format (using client's eCTD templates)Investigator's brochureFDA meeting requests and meeting packagesRepresentation at FDA or EPA meetings and preparation of meeting minutesSCIENTIFIC MANAGEMENT ToxPlus Consulting provides scientific/technical management services for companies and trade association groups to ensure groups stay on top of the science and science related issues.     Chemical regulation and policy monitoringComment development for new regulations or changes to existing regulationsAttendance or representation at regulatory meetings with written report of the meetingScientific literature monitoring reportsScientific conference attendance for intelligence gathering or data presentationsResearch program development, monitoring and managementLiterature reviews of available public data and proprietary dataPosition/white papersManuscript drafting and submission for publicationData compensation management