Harnessing Technology for Regulatory Success
At A-REG, we expertly manage EMA electronic systems, which play an increasingly critical role in regulatory processes. Our support covers the IRIS system—a cornerstone for submissions like scientific advice (SA), paediatric investigation plans (PIP), and procedure management, as well as GMP quality inspections—ensuring seamless interaction across regulatory and quality domains.
We also streamline expert inquiries and guidance requests through the EMA service desk. As EMA encourages these submissions, our efficient facilitation keeps clients compliant and connected.
Our team excels in a range of EMA systems beyond IRIS, addressing diverse regulatory needs with tailored solutions. We adapt our approach to each client’s unique context.
Our offerings include customized training on EMA systems, user access setup, and process development for efficient management. Clients can also opt to fully outsource system operations to us, tailored to their preferences.
With our deep expertise, clients confidently navigate EMA systems, focusing on their regulatory goals with precision and ease while we handle the technical complexities.