Regulatory affairs and strategic guidance

♦ Experience maneuvering products through regulatory agencies, dossier preparation and project management of analytical, toxicological and regulatory submission packages.
♦ Provides compensable data valuation and arbitration expert witness support services.
♦ Design and manage product testing and assessment programs for successful regulatory approval.
♦ Guidance in registration and regulatory affairs for new chemicals, pharmaceuticals, personal care products, natural health products, supplements and pesticides.
♦ Toxicity/safety evaluations, risk and exposure assessments.

Occupational Health and Safety

♦ Assess clients’ business processes to identify possible areas of risk to human and environmental health.

♦ Conduct air quality sampling and analysis to investigate potential health related issues.

Project Management

♦ PRTox will manage your GLP or cGCP (non-clinical and clinical trials) trials for the purpose of regulatory compliance (National and International Standards).
♦ Manage study placement with OECD accredited laboratories.
♦ Conduct independent GLP/GMP/GCP audit of ongoing studies.

Scientific Advice

♦ Counsel clients on the development of projects and policies to ensure compliance of operations with human health and environmental regulatory standards.
♦ Provide assessment for hazardous effects of contaminants released to the environment and work environment.
♦ Prepare and defend the technical dossiers and scientific rationales to facilitate regulatory approvals.
♦ Work with clients to expand research activities to include studies using the Canadian Light Source.

Toxicology Services

♦ PRTox collaborates with several experienced toxicology and analytical laboratories. PRTox provides clients with cost effective and rapid delivery of important GLP compliant regulatory studies.

Compensable Data Expert Witness

♦ Challenge the value of compensable data using an expert witness of data source, relevance, cost and acceptability.
♦ Provide varying degrees of scientifically based review of disputed events for exposure and contaminant related issues.

Risk Assessment (Human and Environmental Health)

♦ Offer expert and professional data collection and complete review of hazard potential with identification of exposure areas that may affect health and safety.
♦ Review analytical, residue and toxicological data using independent unbiased science based review.
♦ Comparative risk analyses.
♦ Analysis of effects of uncertainties in assessments of human exposure and risk.

Analytical Chemistry & Certification

A range of analyses are required for environmental assessments, Health Canada extraction studies for food and food contact materials, personal care products, pharmacokinetics, and medical devices. PRTox provides a sophisticated knowledge for key client industries: pharmaceuticals, agricultural chemicals, industrial chemicals, food and feed, medical devices and personal care products. Clients may rely on this expertise for:
♦ Product chemistry and QA analyses of protocols, reports, laboratory qualifications and GLP compliance.
♦ Residue analyses in plants, animals, food/feed and environmental samples, technical materials and consumer products.
♦ Method development, internal validation, and independent laboratory validation.
♦ Custom design of analytical, toxicological and environmental protocols.
♦ Placement and monitoring of analytical studies and development of rationales.
♦ Identification and analytical assessment of manufacturing contaminants/residues.

Agricultural Chemicals and Crop Protection Agents

PRTox will help your organization effectively and confidently navigate regulatory authorities for innovator and generic chemical applications and assure you of proper data development which may include:
♦ Preparation of registration applications, label amendments, and establishment of MRLs.
♦ Strategic approaches to data development, regulatory interpretation and negotiation, field and laboratory studies for product performance, plant metabolism, and crop residues.
♦ Laboratory toxicology, chemistry, and metabolism studies, environmental fate and effects studies, exposure studies and assessments, safety and risk assessments, and others.
♦ Data call-in responses and data requests that may come from maintenance of registrations.