ToxPlus Consulting provides expertise in global regulations, preparation of regulatory documents and developmental strategy to meet our clients' goals. 


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 monitoring
  • Comment development for new regulations or changes to existing regulations
  • Attendance or representation at regulatory meetings with an overview oral and written report of the meeting
  • Scientific literature monitoring reports
  • Scientific conference attendance for intelligence gathering or data presentations
  • Research program development, monitoring and management
  • Literature reviews of available public data and proprietary data
  • Position/white papers
  • Manuscript drafting and submission for publication


  • Breakthrough therapy designation
  • Non-clinical sections of INDs/NDAs in legacy and eCTD format (using client's eCTD templates)
  • Investigator's brochure
  • Carcinogenicity special protocol assessment preparation
  • FDA meeting requests and meeting packages
  • Representation at FDA or EPA meetings and preparation of meeting minutes
  • Developmental strategy and regulatory intelligence (global)

ToxPlus Consulting offers a complete range of toxicology, regulatory affairs and scientific management consulting services that span the globe.

ToxPlus Consulting provides toxicology expertise spanning drugs, biologics, and chemicals.  We work to develop the best approach to meet the clients' needs.   

  • Pre-Clinical IND-enabling toxicology and safety pharmacology study management
    • Study identification and protocol design
    • Laboratory proposal management and assistance with laboratory selection including site visits
    • On-site study monitoring
    • Study data interpretation and study report review
  • Participation in meetings with regulatory authorities
  • Data Gap Analysis
  • Safety assessments of excipients, impurities, and APIs
  • Safety assessments of extractables and leachables from medical devices
  • SDS and Hazard band determinations