Description

Regulatory issues are a permanent concern in clinical research for your submission of a new compound or device to be accepted, you need to present error-free, quality-controlled regulatory documents. Our highly- qualified regulatory team prepares, coordinates and manages all the activities associated with clinical trial submissions for companies throughout Europe. Our services cover: Medical writing of: protocols investigational brochures and annual updates clinical study reports informed consent forms benefit-risk assessments reports Clinical development plans Medical and scientific literature reviews Clinical sections of Common Technical Documents (CTDs) Pharmacovigilance documents Preclinical study reports, expert reports and summaries Data safety monitoring boards Written and tabular summaries Completion of CTA forms and/or ethic committee forms Discussion and meetings with competent local authorities

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