Preparation of Documents

TRAC has a wealth of experience in the preparation of regulatory documentation. This includes, but is not restricted to:

Clinical Trial Applications
Marketing Authorisation Applications
Common Technical Document (CTD) - Module 1-5
Quality Overall Summary
Summary of Product Characteristics
Patient Information Leaflet (PIL)
Labelling
Post-Marketing Applications (Variations and Renewals)
PSUR
CEP Applications
Active Substance Master Files (ASMF)
Orphan medicinal product designation applications
Review of advertising and promotional material - We can advise on your advertising and promotional material to ensure compliance with EU Directives and UK ABPI Code of Practice
Electronic Submissions (eCTD)

The Company has experience and in-house capability to produce electronic submissions, as follows:

Preparing submission documents in electronic formats
Compiling electronic submission dossiers with reference to specified standards, including eCTD
Analysis of process requirements for assembly of electronic submissions