Services
Preparation of Investigational Medicinal Product Dossier (IMPD)Preparation of Marketing Authorization Dossier
We offer Guidance and Preparation of all documents for all CTD Modules:
Quality:
Full development guidance and preparation of documentation:
•Preparation of Module 3 S+P
•Chemical/pharmaceutical Module 2.3 (Quality Overall Summary)
•Drug Master files (DMF)
•Site Master files
•Audit of API and Drug Product Manufacturers
•Chemical/pharmaceutical Module 2.3 (Quality Overall Summary)
•Drug Master files (DMF)
•Site Master files
•Audit of API and Drug Product Manufacturers
Safety:
Full development guidance and preparation of documentation:
•Full pre-clinical development guidance together with CERB France
•Preclinical expert advice, and preparation of Module 2.4 (Nonclinical Overall Summary) and 2.6 (Nonclinical Summary)
•Compilation of Module 4
•Preclinical expert advice, and preparation of Module 2.4 (Nonclinical Overall Summary) and 2.6 (Nonclinical Summary)
•Compilation of Module 4
Efficacy:
Full development guidance and preparation of documentation:
•Clinical trial strategy
•Protocol preparation and biostatistics for phase I-II.
•Data management
•Preparation of Modules 2.5 (Clinical Overall Summary) and 2.7 (Clinical Summary)
•Compilation of Module 5
•Protocol preparation and biostatistics for phase I-II.
•Data management
•Preparation of Modules 2.5 (Clinical Overall Summary) and 2.7 (Clinical Summary)
•Compilation of Module 5
