clinical trials made easy
Regulatory Affairs
Our team in charge of regulatory affairs and submissions to authorities, is composed of experienced experts, who can guide you through the intricate area of regulatory issues and approval timeframes.
They will also provide you with all the options to help you choose the best strategy.
From the importance of
Regulatory Affairs in Clinical Trials
Regulatory affairs play a key role in the clinical trial process ensuring that news treatments or devices will meet all legal and safety requirements before they are released. Our team of CRAs is at the forefront to navigate complex regulatory landscapes, ensuring compliance and supporting the compliant progression of trials.
Our support can go way beyond Spain. We are also able to help you with a large set of governing authorities like the EMA and the FDA.
What CRAs do for you
Regulatory submissions
Our CRAs will assist you in the preparation and submission of regulatory documents to the competent authorities. Thanks to their longtime expertise, you are sure that all the required paperwork will be filled out accurately and on time.
Regulatory guidance
You can count on our CRAs experience to guide you though regulatory hurdles. Their proactive approach towards regulatory challenges will definitely save you time and energy.
COMPLIANCE MONITORING
It is part of our CRAs' missions to monitor your clinical trial so that it complies with regulatory requirements and internal protocols. They will ensure that the project follows the Good Clinical Practive (GCP) standards in order to guarantee safe data collection.
LIAiSION WITH REGULATORY AUTHORITIES
Our CRAs act as intermediaries between the sponsor and regulatory bodies. Their reactivity allows to address problems promptly with no backlogs.
Documentation and RePORTING
Our CRAs will take care of maintaining documentation including case report forms, regulatory correspondence and progress reports. That way, you trials' regulatory journey is absolutely transparent.
TRAINING AND EDUCATION
Our CRAs make sure that all stakeholders are properly training on regulatory requirements and complicance. This includes educating clinical staff, investigators and others team members about regulatory expectations and procedures. This dedicated time is crucial to a trouble-free trial.