Help with various aspects of drug, biologic and device development plans, as well as individual trial protocols.

Reviewing and drafting of statistical analysis plans, clinical study reports and their contributions to the Common Technical Document.

Support for CHMP Scientific Advice and Protocol Assistance meetings, FDA meetings and meetings with other National Competent Authorities. At the time of submission of a dossier, support during the review process, including responses to questions, rehearsals for Advisory Committee meetings, SAGs, oral explanations, etc.

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