RSA provides advice and support to the agrochemical, general chemical and pharmaceutical industries in the context of emerging regulatory change and legislation, enabling companies to gain and maintain optimal registrations for their products.
With specialist science skills in key disciplines, a proven track record and broader regulatory science experience, we can help with one-off issues or work more closely with your company to develop regulatory strategy and manage long-term submission programs through to initial registration and subsequent maintenance.
As regulation of all chemicals and pharmaceuticals becomes more complex, we can help you understand the impact of regulatory changes on the labelling and use of your product in the marketplace. In toxicology, we offer specific experience in interpretation and impact of CMR and Endocrine Disruption related issues, and of the role of metabolism and kinetics in species-specific responses to xenobiotics. We can help design and run programmes of work to support the registration of agrochemicals, chemicals and pharmaceuticals from early development to market approval.
Sectors select a sector to find out more
RSA has extensive experience in gaining and maintaining product registrations in the EU and US. Our respected experts bring together high-quality scientific expertise and in-depth knowledge of regulatory processes to ensure the optimum outcomes for our clients. From data-gap analysis and Study Monitoring of toxicology packages, through project management, preparation of regulatory documents, advocacy and representation through regulatory processes, RSA provides a comprehensive package of techno-regulatory services.
RSA has a number of highly experienced consultants with decades of experience of taking drugs from discovery through clinical development and on to the market. Our expertise includes Toxicology, Pathology, Drug Metabolism and Environmental specialist areas. From Study Monitoring individual studies or designing non-clinical safety packages, to authoring and defending regulatory submissions worldwide, RSA can help clients to accelerate development, reduce costs and reach the market sooner.
Expertise Our consultants offer expertise in the following areas, see our expertise to see who can best assist you
- Advocacy
- Dossier Compliance
- Mechanistic
- Regulatory Toxicology
- Project Management
- Metabolism and Kinetics
- Pathology
- Environment
- Oncogenicity
- Risk Assessment
- Endocrine Disruption
- Regulatory Affairs
- Analytical Chemistry
- SAR
- Reprotoxicology
- Safety Pharmacology
- Operator Exposure
- Neurotoxicology
- Genetic Toxicology
Services Our consultants offer the following services
- Pathology slide reading and peer review
- Mode of Action/weight of evidence assessments
- Study Monitoring
- Project Management
- Risk Assessment
- Data gap analysis
- Regulatory document preparation
- Advocacy
- Literature reviews