Pharmaceutical and healthcare consulting expertise in regulatory affairs, nonclinical toxicology, and risk assessment for all stages of product development and beyond.
The development and manufacture of pharmaceutical and healthcare products requires a clear understanding of safety, efficacy, and quality aspects in a highly regulated environment. Challenges may include the design and execution of toxicology and safety testing programs, the development of regulatory strategies, the preparation and submission of regulatory documents, or the need for risk assessments of occupational and product safety, to name just a few.
Intertek’s Pharmaceutical and Healthcare Consulting Group consists of toxicology and regulatory affairs specialists with significant experience and technical expertise, as well as professional credentials such as PhDs, DABTs and RACs. Across the company, our staff include senior specialists who have been with the consultancy since the time of the legacy Cantox Health Sciences organization. For more than 25 years, our team has been providing expert guidance and consulting services to the pharmaceuticals, biotechnology, and medical device industries, whether for products in development or those on the market.
Our core services focus on 3 main areas wherein we collaborate to provide our clients with seamless support ranging from drug development strategies to regulatory agency submissions and interactions, to risk and safety assessments.
Our Team – Your Partner in Success
The Intertek team has a breadth of expertise and services that focuses on scientific rigor, quality, regulatory excellence, and project success, helping to assure clients that they are working with a team of experts who care. Depending on the needs of the company, we can work on specific single tasks or integrate a program of activities to add depth and support to our clients' overall team.
Toxicology, Strategy, & Development
Expert toxicology and drug development consulting services through a team with extensive hands-on industry experience.
Regulatory Affairs
Establish strategies, navigate regulatory responsibilities, and prepare and submit dossiers in multiple jurisdictions throughout the product life cycle.
Toxicological Risk Assessment
Impurity qualifications, ICH M7, addressing nitrosamines, PDE derivations, and occupational exposure assessments, etc.
