Studio  Governatori

Pharmaceutical Development Consulting

Dr. Claudio Governatori 

 

     


 

Dossier Preparation / Maintenance

CTD preparation in NeeS / eCTD format:

 

Module 1

Information on documents
Risk management plans
Pharmacovigilance system
Text for SPC, PL, Labelling
Consultations with target patient groups for the PL (Readability test)
 Application forms and annexes

Module 2

QOS
NCO, CO (in cooperation with partners)

Module 3

Information on necessary documents and development steps
Dossier compilation from raw data

Module 4-5

Literature search
Biowaiver

 

Post-approval Dossier maintenance:

Reviews and updating of approved dossiers, regulatory/quality gap analysis, including:

Due diligence for the in-licensing assessment of dossiers (gap analysis)
Renewal of marketing authorization
Product Extensions
Variations Submission
Product Information Update (SmPC, PIL, labeling)

 

 

Studio Governatori – P. IVA 01807810567 - c/o Centro Commerciale Rio,  Loc. Pizzo Garofalo -  01033 CIVITA CASTELLANA (VT)

Tel. +39 761 513356 Fax +39 761 1703517  -  e. mail:  claudio@studiogovernatori.it

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