Technical and Regulatory support

CEBIPHAR, technical and regulatory services company, provides you with regulatory consultancy for the following topics:

• Dossier Audits, Dossier Gap Analysis and Dossier writing
• Technical and regulatory assessment of the CMC file
• Technical and regulatory assessment of ASMF or scientific data for an active ingredient
• Writing of the Market Authorization file (Modules 3 and 2.3 / Part 2 and 1.C)
• Writing of the dossier (Module 3.2.S) for a CEP
• Writing of the IMPD dossier
• Variations in the Quality section: strategy, classification and writing
• Assessment of industrial process in relation to the registered dossier
• Constitution of eCTD baseline: compilation of your initial files, answers to questions and variations, and conversion in CTD format