What is a Toxicology Consultant?

The services a Toxicology Consultant provides are diverse and vary from one individual consultant to another based on the Toxicology Consultant’s expertise and experience.

General

  • Designing, monitoring and interpreting nonclinical safety studies
  • Knowledge of GLPs and technical auditing
  • Serving on Expert Panels and Scientific Advisory Boards
  • Reviewing scientific literature
  • Writing Expert Reports, White Papers, Study Report, product labels, Material Safety Data Sheets, Investigator’s Brochures, etc.
  • Soliciting bids, evaluating and selecting Contract Research Organizations (CRO)
  • Acting as liaison between sponsors and global regulatory authorities (FDA, EMA, EPA, Health Canada, etc.)
  • Gap analysis and needs assessment

Pharmaceutical

  • Preparation of global regulatory submissions (IND/CTA, NDA/BLA, etc.)
  • Responding and helping resolve US and international regulatory issues
  • Assisting in new product development and existing product defense
  • Provision of subject matter expertise during due-diligence activities
  • Project Team subject matter expertise and leadership
  • International and domestic pharmaceutical and medical device development
  • Selection of clinical starting dose based on nonclinical safety data
  • Registration and regulation of imported drugs and chemicals

Government/ Other Industry

  • Occupational exposure and effects of exposure
  • Chemical causation of cancer, birth defects, and other disease states
  • Cosmetics and consumer product development
  • Food additive petitions, GRAS evaluations, food contact notifications
  • Dietary supplement 75-day notice development
  • Pesticide exposure claims
  • Environmental pollutants in soil, water and air
  • Superfund and toxic waste site risk assessment
  • Indoor air pollutants and sick building syndrome
  • Safety assessment of military and police agents
  • Registration and regulation of imported chemicals

Legal

  • Litigation support
  • Expert witness
  • Communication of exposure risks to juries, the press and the public.
  • Toxicological effects of alcohol and drugs of abuse
  • Worker’s compensation litigation

The Origin of the Roundtable of Toxicology Consultants

Dr. Richard Parent founded the Roundtable of Toxicology Consultants (RTC) in 1986 following ongoing discussions with active toxicology consultants at Society of Toxicology meetings dating from 1984.  Since that time the RTC has become the oldest and largest organization of independent consulting toxicologists in the world.  Over the years he has actively and graciously  helped many toxicologists make a successful transition from industry, government or academic careers in toxicology to success as independent consulting toxicologists who each day make significant contributions toward advancing the practice of toxicology in many unsung practical ways.

Not surprisingly, the early history of the RTC, from 1984 through 1988 was a formative time.