Regulatory Affairs
RSA provides expert advice and support, enabling clients to gain and maintain product approvals.
Our Regulatory Affairs Services
Pre-clinical Strategy
With extensive experience in all aspects of toxicology program design and conduct in drug development from DRF studies to pivotal toxicology studies for FTIM submissions, our experts can support your pharmaceutical pre-clinical strategy.
Project Management
RSA can support all levels of project, be it study management, dossier preparation, datacall management or Task Force management. Our project managers have years of experience, and can positively influence decision making and project delivery.
Regulatory Strategy
RSA has experience in providing regulatory support to meet business objectives, including the development of regulatory strategies, governance and budgetary oversight. Our consultants can provide advice and support during all stages of the registration or renewal process, and have a proven track-record in the successful registration and defence of active substances and products in the EU and globally.
Regulatory Affairs Specialists
Our Team
RSA's world-class consultants are committed to providing you with the support that will address and resolve complex issues and achieve regulatory compliance.
Our Team >
Pharmaceuticals >
Agrochemicals >Blog
Meet The Team – David Andrew
Reviewing the thoroughness of human safety testing for succinate dehydrogenase inhibitors: fluopyram as a case study
Applicability of kinetically-based maximum dose studies for hazard and risk assessments of the fungicide fluoxapiprolin
Regulatory Affairs Service FAQ's
RSA provides regulatory affairs consulting services to clients across the agrochemical and pharmaceutical sector, providing regulatory support at all stages, from early planning through registration, renewal and post-approval defence.
RSA’s regulatory affairs consultants develop tailored regulatory strategies aligned with business objectives, supporting interactions with authorities, managing data calls and providing advocacy during registration, renewal and defence processes.
Simply contact RSA to discuss your regulatory challenges and objectives. Our regulatory affairs associates will assess your needs and propose a tailored support approach aligned with your development and approval goals.