Increased healthcare spending in Turkey has resulted in growing demand for medicinal products. As the Turkish Medicines and Medical Devices Agency (TMMDA) reviews and approves the medicinal products’ marketing in the country, aligning with its unique requirements for compilation and submission of dossiers in CTD format and conversion to paper format for legacy products can prove quite challenging without expert assistance. Additionally, gaining a foothold amid rising competition requires informed decision, effective Regulatory and market pathway for successful product launch and adjusting to changes in trends in extended product life cycle.
To streamline the submissions to TMMDA in a compliant way, Freyr provides Regulatory assistance in devising a strategic pathway for product development and market entry. Besides providing authoritative market intelligence, Freyr also assists in dossier compilation and documents conversion from paper to CTD format for successful submissions as per the TMMDA regulations.
- Regulatory submission road map for medicinal products registration
- Regulatory consultation during the development of the medicinal products
- Pre-submission administrative activities, pre-submission interactions with health authority (HA)
- Regulatory assessment of source data from R&D and manufacturing site (executed data) for their adequacy
- Compilation and submission of the dossiers to HA in CTD format in line with the TMMDA
- Assistance for strategy, compilation and submission of post-approval changes
- CTD conversion of legacy products from old/paper format
- Designing of specifications for Active Pharmaceutical Ingredient (API), finished product & intermediates
- Limits for impurities including genotoxic & elemental
- Protocols Design for bio-equivalence, stability, analytical method validation, exhibit batch, process validation
- Change control evaluation and compliance activities
- HA query response support on pre and post-registration for medicinal products
- Product re-registration (renewal) to ensure continuity of supply in the market