Efficient regulatory management is fundamental to achieving timely study start-up and maintaining compliance throughout clinical development. CRS provides comprehensive Regulatory Affairs support to guide sponsors through the evolving regulatory landscape and ensure that clinical trials are conducted in accordance with applicable EU and national requirements.

We manage the full regulatory pathway from early regulatory strategy through study approvals and lifecycle maintenance. Our services include preparation, review, and coordination of Clinical Trial Applications (CTAs), ethics committee submissions, and regulatory correspondence. We support both early-phase and later-phase programs, ensuring that submissions are complete, accurate, and aligned with current regulatory expectations.

CRS provides hands-on support for the preparation and quality control of essential regulatory documentation, including study protocols, investigator brochures, informed consent forms, patient information sheets, and safety documentation. All materials are reviewed for consistency, compliance, and readiness for submission, reducing the risk of questions, delays, or deficiencies during review.

During study conduct, we support regulatory maintenance activities, including protocol amendments, substantial modifications, safety notifications, and annual reporting. We coordinate communication with regulatory authorities and ethics committees, ensuring timely responses and clear documentation of regulatory decisions.

Our Regulatory Affairs services are fully integrated with project management and clinical operations, enabling efficient coordination and proactive issue resolution. Through a structured and compliant approach, CRS helps sponsors minimize regulatory risk, avoid delays, and establish a strong foundation for successful clinical trial execution.

‍

‍