Ethical & Regulatory Management
We manage the regulatory process with precision, ensuring timely approvals while complying with ethical and regulatory requirements in every jurisdiction. Our expertise enables us to resolve any issues that arise during the process, always adapting to the specific requirements for ophthalmic treatments and devices.
Submission to Ethics Committees (ECs/IRBs)
We prepare and submit all the required documentation for the ethical evaluation of each trial, ensuring compliance with participant protection standards and current regulations. Our meticulous approach facilitates ethical approval and ensures that patient rights and safety are always protected.
Management with Competent Health Authorities
We coordinate and manage all submissions and communications with the relevant health authorities to secure study approval. We ensure that each dossier complies with regulatory requirements, minimizing delays and optimizing review timelines so that the trial can proceed efficiently and in full compliance with regulations.
Registration in EU-CTR and ClinicalTrials.gov:
We manage the registration and maintenance of clinical trials in international databases, such as the EU-CTR and ClinicalTrials.gov, ensuring that the study complies with global transparency and visibility standards. This facilitates access to information for the scientific community, participants, and regulatory authorities, reinforcing the trial’s credibility and impact.
Response to Regulatory Requirements:
We proactively address any queries or requests for additional information from regulatory authorities, ensuring that all legal and regulatory requirements are met. This agile and organized management approach enables rapid issue resolution, maintains the study timeline, and ensures the continuous progress of the trial without compromising quality or data integrity.
End-to-End Monitoring
We provide continuous oversight throughout the entire regulatory process, ensuring agile and proactive follow-up at every stage. This approach allows us to anticipate potential issues, maintain established timelines and requirements, and secure final approval efficiently without compromising the quality or integrity of the study.
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