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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Nonclinical and Clinical Overviews (Modules 2.5 and 2.4)

BioVentures Consulting Limited has experience and expertise in project managing and technical document compilation of the Module 3, 4 and 5 summary documents. These are: the Quality Overall Summary (Module 2.3), the Nonclinical Overview (Module 2.4) the Clinical Overview (Module 2.5); and the Nonclinical written and tabulated summaries (Module 2.6) and Clinical written and tabulated summaries (Module 2.7).

The Clinical Overview is arguably one of the most important documents of a Marketing Authorisation Application

The Clinical Overview in Module 2.5 is arguably one of the most important documents of a Marketing Authorisation Application (MAA) or Biologics License Application (BLA) since it may be one of the first documents a reviewer will assess when orientating themselves to a submission (though note, in Europe assessors often adopt a ‘top down’ approach, assessing key summary documents first and working down to the data; where as in the US assessors often adopt a ‘bottom up’ approach and derive their own view of summary statements by a thorough an assessment of the core data).

The Clinical Overview is intended to provide a critical analysis of the data

In any case, the Clinical Overview will contain key positioning statements for the SmPC and product label. The Clinical Overview is not an opinion of an expert, rather it is a factual document written which presents the conclusions and implications. Neither is it a recapitulation of text and data presented in the clinical Module 5. The Clinical Overview is intended to provide a critical analysis of the data. BioVentures Consulting Limited has expertise in the critical appraisal of the data package and of compiling the Clinical Overview with an assessment of the key issues to highlight.

BioVentures Consulting Limited also offers services in the compilation of the Nonclinical Overview, providing a factual summary of the pharmacology, pharmacokinetics and toxicology aspects of our client’s development programme.

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