Services
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Leaflet preparation and design
Amend your existing leaflets
Interviews
Submission
Report Compilation
Assistance through the Regulatory Authority review
Advice on bridging products to reduce costs
Regulatory strategy for submissions - Fast turnaround |
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THE TEST
Review of the Package Leaflet
Suggestions for amendment if necessary
Protocol design
Questionnaire design
Pilot testing - Phase 1 testing is performed on 10 subjects
Phase 1 results are analysed and reviewed for quality |
Suggestions for amendment to the Package Leaflet are made if necessary
Phase 2 testing is performed on 10 subjects
Phase 2 results are analyised and reviewed for quality
On completion of successful testing, the Final Report is created in English and presented in hard copy and eCTD
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