Services

Help navigate innovator and generic chemical applications through Health Canada's PMRA.

Effectively prepare Fertilizer and Supplement applications for successful CFIA approval.

Direct and manage data development, regulatory interpretation and negotiation, field and laboratory studies for product performance.

Independent Study Director services for toxicology, chemistry, and metabolism, e-fate and effects studies, exposure studies for safety and risk assessments, and mitigation measures.

Provide Canadian Agent services for foreign clients.

Help maneuver products through regulatory agencies, by starategic and germane dossier preparation and project management of all GLP, non-clinical compliant studies.

Assist with design and management of product testing and assessment programs for successful regulatory approval.

Provide guidance in registration and regulatory affairs for new chemicals, pesticides, fertilizers and supplements, pharmaceuticals, personal care products, and natural health products.

PRTox will appraise compensable data lists, interpret data source, relevance, cost and acceptability for Generic company to enter market.

PRTox will manage your GLP or cGCP (non-clinical and clinical trials) trials for the purpose of regulatory compliance. In addition PRTox can conduct pre-inspection GMP audits for chemical manufacturing and cannabis production.

PRTox collaborates with several experienced toxicology CRO's and analytical service labs to provide clients with cost effective and rapid delivery of important GLP compliant regulatory studies.

Provides professional data collection and review for hazard potential.

Review purity analysis, contaminant or residue and toxicological data for independent unbiased science based assessment.

Provide Phase II Environmental Site Assessment reports (Designated Qualified Person) as required by the Saskatchewan Environmental Code.

We can project manage, develop or be study director for analytical chemistry studies or to conduct QA analyses of protocols, reports, or audit laboratory qualifications for GLP compliance.

Project manage residue analysis of plant, animal, food/feed and environmental samples and product vigilance for consumer products.

Custom design and conduct analytical, toxicological and environmental protocols and GLP compliant studies.

Panage cannabis analysis for CBD or THC to assess commerical purity compliance.