Document Preparation and Evaluation

Franciosi Consulting has extensive experience in preparing review documents for use by in-house project teams as well as Investigator’s brochures (IB), Common Technical Documents (CTD), Investigational New Drug applications (IND) and Investigational Medicinal Produce Dossiers (IMPD) for regulatory submission. Franciosi Consulting has well established and tested QC and verification procedures and is compliant with the Copyright Licensing Agency.

In-licensing and out-licensing of drugs in early development is a major feature of the pharmaceutical industry and requires a thorough and competent review of the data. Franciosi Consulting will assess the nonclinical dossier for completeness, technical competence and scientific and regulatory content and provide the Sponsor with an assessment of any likely issues and data gaps.