A MUST-HAVE AND A UNIQUE EXPERTISE

CERC ensures that all regulatory requirements are fulfilled before patient enrolment. Regulatory support is crucial for the success of the trial. It is affected by guidelines, standards, specific requirements…

Using the required format increases successful review.

CERC can assist you in preparing and submitting your regulatory application, from the beginning of the process until you apply.

Ensuring compliance with all regulatory agency technical requirements so that your submission will pass technical validation and arrive to the reviewers without delay is an expertise we acquired.

Regulatory agencies are various around the world. Submissions can be sent electronically through an Electronic Submissions Gateway when there is one or through document publishing, CDISC dataset preparation, SPL build, standard letter or A4 paper submission printing for agencies or EU Member States.

Because of our knowledge of the regulatory authorities expectations, we have an excellent reputation for filing high-quality, easily reviewable forms and applications.