Ethical & Regulatory Management
We manage the regulatory process with precision, guaranteeing agile approvals and complying with ethical and regulatory standards in each jurisdiction. Our experience allows us to solve any inconvenience that may arise during the process, always adapting to the specificities of the requirements for the approval of ophthalmic treatments and devices.
Submission to Ethics Committees (ECs/IRBs)
We prepare and submit documentation to ensure ethical evaluation and protection of the participant.
Management with Competent Health Authorities
We coordinate applications to the authorities to obtain approval of the study.
Registration in EU-CTR and ClinicalTrials.gov
Enrollment and registration management of the trial in international databases, such as EU-CTR and ClinicalTrials.gov, to ensure the transparency of the study and its global visibility.
Response to Regulatory Requests
We address and resolve any inquiries or requests for additional information from regulatory authorities, ensuring compliance with established requirements for proper study progress.
Continuous Follow-Up Until Final Approval
We provide ongoing monitoring of the entire regulatory process, ensuring proactive and timely follow-up to achieve approval without deviations from established timelines and criteria.
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