Smithers Viscient partners with you to provide a well-defined consultancy strategy, specific to the unique properties of your product, targeted at the respective environmental compartments of concern. Our extensive experience in environmental safety testing and risk assessment strategy design, coupled with a sound understanding of regulatory requirements, facilitates the avoidance of potential obstacles and saves you time and money.
European consultancy services
Our European consultancy team offers consulting for pharmaceutical, veterinary medicine, agrochemical, biocides, and industrial registrations in Europe, as well as pharmaceutical registrations in the United States, and new substance notifications in Canada and Australia. The team is led by Alison Fournier, Acting Director of Ecotoxicology and Regulatory Services.
Services include initial consultation, planning with clients and the regulatory agencies to agree on the appropriate strategy, advice on test designs, project management and monitoring of regulatory studies through to conducting environmental risk assessments including compilation of expert reports and partial/full registration dossiers. We also offer post-submission support including direct involvement in meetings with the EU/US authorities to aid successful registration.
North American consultancy services
Our North American consultancy team provides coordination and planning of environmental testing, including assistance in meeting deadlines, study guidance, and solution generation for technical challenges, focusing primarily on NAFTA registrations. The service is led by Dr. Kalumbu Malekani, North American Technical Director, and provides scientific project management support with higher-tier study design and regulatory strategy. Dr. Malekani helps with co-designing programs and supervising projects across departments or multiple facilities and geographical locations.
Contact us for more details about how Smithers Viscient can help you to identify critical steps, integrate your program information, recognize challenges to program execution, or craft solutions to achieve expedient registration.