PRODUCT REGISTRATION AND PROJECT MANAGEMENT
STRATEGIC & REGULATORY CONSULTANCY
OTHER APPLICATIONS
ADMINISTRATIVE FILES
- Applications ex art. art. 53 in Italy
- Applications ex art. 34
- Applications ex art. 40 (mutual recognition)
- Applications ex art. 43 (product renewal)
- Technical variations files (major and minor changes, change in classification/labelling)
- Parallel trade
- Notification of experimental tests
- Comparative Assessment (Italian market)
- Technical Equivalence
- Free Sale Certificates (Italy)
- Changes/extensions in label (i.e. manufacturing, packaging, labelling plants/sites, size variation, change in product’ name/company name, holder’ transfer, product’ withdrawal)
- Official Representation c/o Italian Authorities through Power of Attorney
Data Gap Analysis
Preliminary Risk Assessment
Project budgeting
Pre-submission meetings
Letter of Access (writing/revision)
TESTS AND DATA MANAGEMENT
Contracting Labs/CROs
Studies’ scheduling
Monitoring of studies
Visit to tests (including field trials)
DRR (DRAFT REGISTRATION REPORT)
Preparation of dossier for authorization and/or renewal of product
National Addenda for Italy
Administrative documents
Application and follow-up
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