PRE-SUBMISSON ASSESSMENT
Product Evaluation and Classification Assessment
Dossier Assessment and GAP analysis (Document Assessment, etc.)
Strategical Regulatory Advice
National Legislation Interpretation
External Resource/Expert Management
UTS Company Registration Support
etc.
SUBMISSION
Document Registration Activities
Product Registration Activities
Labeling Support
IFU/DFU Support
Liasion with Health Authorities
Translation Services
etc
POST-AUTHORIZATION ACTIVITIES
Post-Authorisation UTS Maintenance
Change Control Assessment and Registration Amendments (Documents, Products, Etc.)
Preparation of Responses to Regulatory Agencies Questions
Other Technical Expert Services
Labeling Amendments
IFU/DFU Amendments
Product Movement Notifications
Pharmacovigilance Activities (Field Action Reports, Manufcaturer's Reports, Recall Actions, etc)
Advertising and Promotional Material Review
etc.
OTHER ACTIVITIES
Registration Holder Services
Pharmacovigilance Services
Reimbursement Submissions and Management
Outsourced Regulatory Affairs Department
Training
etc.
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