REGULATORY AND GOVERNMENT AFFAIRS

TNC offers a full range of regulatory and government affairs services, helping local and international pharmaceutical and biotechnology companies to be granted marketing authorization approvals for their products in Turkish market in a timely and cost-effective manner.

• Advice on regulatory requirements and application strategies 
• Negotiations with the authorities
• Preparation of all parts of a registration dossier 
• Compilation of registration dossiers in any format, especially as Common Technical Document (CTD) 
• Follow-up of submitted documentation
• Dealing with deficiency lists and variations 
• Preparation of Drug Master Files
• Applications of certificates of suitability 
• Expert opinions and reviews, especially for regulatory compliance 
• Periodic Safety Update Reports (PSUR) 
• Marketing authorization renewals 
• Change of ownership 
• Pricing and reimbursement
• Designing and publishing of advertising materials
• Pharmacoeconomics Consultancy with international experts