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 >