Clinical Operations
&
Regulatory Advisory
our expertise
We provide clinical and regulatory support to Research teams and European consortia, ensuring accurate documentation and compliant submissions.
Our expertise helps create strategic roadmaps that keep research moving instead of slowing down in paperwork.
Let’s solve Problems
How We Help You Succeed…
Clinical strategy & roadmap development
We design clear clinical roadmaps that guide teams through each phase, ensuring research progresses efficiently and never stalls due to administrative complexity.
Regulatory documentation & submissions
We prepare, review and coordinate all regulatory documentation required for clinical activities, ensuring accuracy, compliance and timely submissions.
Support for EU-funded projects & consortia
We help European consortia meet clinical and regulatory requirements within Horizon Europe and other EU frameworks, aligning scientific goals with compliance needs.
Clinical operations & monitoring guidance
We provide expertise in clinical operations, monitoring plans, site coordination and quality oversight to ensure smooth study execution.
Compliance with ethical and regulatory standards
We ensure that all clinical activities meet EU and national regulatory expectations, ethical guidelines and Good Clinical Practice (ICH-GCP).
Coordination between scientific teams & regulatory bodies
We act as a bridge between researchers, institutions, ethics committees and regulatory authorities, facilitating communication and reducing delays.
Laura González Rosales
about me…
I am a clinical research professional with over twenty years of experience coordinating complex trials, leading R&D&I activities across multiple centers, and managing all clinical, regulatory and operational aspects of national and international studies.