Our team of experienced experts will guide you through regulatory affairs, providing exceptional insights and strategies. Thanks to our broad experience and knowledge, we ensure your project is perfectly prepared for interaction with international authorities. Whether your project is planned in Europe or globally, we have the competence and global reach to tailor to your unique needs.
REGULATORY CONSULTING
At SLS Europe, we understand the significance of successfully navigating the ever-evolving regulatory landscape. Our regulatory consultancy services are designed to support your product development projects with the scientific, operational, and regulatory expertise needed to succeed in regulatory processes.
Operational Excellence, Scientific Competence, Regulatory Expertise
Scientific Advice Meetings
Our regulatory consultancy service includes preparation and conduct of scientific advice meetings with regulatory bodies. We assist you in formulating comprehensive strategies and preparing briefing packages tailored to your project needs. Together, we work towards obtaining the valuable regulatory feedback and endorsement necessary to steer your project towards a successful outcome.
Regulatory Submissions
Our service extends to clinical trial applications and common technical document submissions to regulatory bodies. With support of our specialized experts, you ensure that submission packages are thoroughly prepared and aligned with the regulatory expectations.
Collaborative Partnership
At SLS Europe, we pride ourselves on fostering a collaborative partnership with our clients. We appreciate the uniqueness of each project and tailor our services accordingly. Our team becomes an extension of yours, working hand in hand to address challenges, find solutions, and embrace opportunities. Together, we navigate the regulatory landscape with confidence, knowing that your success is our shared objective.
Our Service Models
Fee-for-Service
We offer fee-for-service models for defined working packages out of our diverse service portfolio.
Consultancy-on-Demand
Our service on demand is ideal for companies that need support on short notice or within an area beyond their internal expertise.
Interim Management
Our clients have the opportunity of complementing their existing management with our experts over a designated period of time. This cooperation may also be based on a shared risk/benefit model.