We offer all services related to clinical trials from start to finish, from regulatory to close-out procedures.
IRB / IEC submission
Our commercial IRBs help speed up your regulatory process.
Patient recruitment and selection of right patients for the study
Coordination of protocol’s study visits, CRF completion, IRB reporting, etc.
Help for our sponsors
We also help sponsors that have no presence in Mexico by providing them with all regulatory services, such as:
Preparation of the regulatory documents
We help our sponsors with the preparation of the documents needed for the submission to the Mexican Ministry of Health, Cofepris (Comisión Federal para la Protección contra Riesgos Sanitarios) for review and approval.
Submission of the regulatory package
We help you submit the regulatory package of the clinical protocol to the Cofepris.
Import permits for study drug.
Scheduling and attending appointments with Cofepris
We help you with scheduling and attending appointments with Cofepris’s deparments on behalf / along with the sponsor.
We can also help you with obtaining certified translation of documents and interim progress reports and final reports to Cofepris.