🇹🇷 Regulatory Affairs Services – Turkey
REGULATORY NEXUS GLOBAL
Turkey Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services and product registration support for Turkey.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Turkish regulatory framework and successfully registering their products for the Turkish market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Turkey regulatory authority requirements.
Turkey Regulatory Authority
Pharmaceutical products, medical devices and cosmetics in Turkey are regulated by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health Turkey.
The authority is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, biological products and medical devices
• Regulation of cosmetics and healthcare products
• Licensing of pharmaceutical importers, manufacturers and distributors
• Pharmacovigilance and post-marketing surveillance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with TİTCK regulatory requirements.
Our Mission
To simplify Turkey regulatory compliance and enable companies to successfully register and market their products in Turkey through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Turkey
Pharmaceutical Product Registration
We prepare Turkey-compliant pharmaceutical regulatory dossiers for submission to the Turkish Medicines and Medical Devices Agency.
Our services include preparation of:
• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)
All dossiers are prepared according to Turkey regulatory guidelines and international regulatory standards.
CTD / eCTD Dossier Preparation
Turkey follows the Common Technical Document (CTD) and electronic CTD (eCTD) format for pharmaceutical product registration.
Our CTD services include:
• Module 1 – Regional Administrative Information (Turkey-specific)
• Module 2 – Quality Overall Summary (QOS)
• Module 3 – Quality / CMC Documentation
• Module 4 – Non-Clinical Study Reports
• Module 5 – Clinical / Bioequivalence Study Reports
Our regulatory experts ensure dossiers comply with ICH guidelines, EU regulatory alignment and TİTCK submission requirements.
Pharmaceutical Registration Process in Turkey
The general process for pharmaceutical registration in Turkey includes:
Appointment of a local Turkish Marketing Authorization Holder (MAH).
Submission of the eCTD regulatory dossier to TİTCK.
Technical evaluation of product quality, safety and efficacy.
GMP inspection and regulatory review.
Approval and issuance of marketing authorization in Turkey.
The registration process typically takes 12–18 months depending on the product type and regulatory review timeline.
Regulatory Services for Multiple Product Categories in Turkey
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Food Supplements
Food supplements in Turkey are regulated through the Ministry of Agriculture and Forestry.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Products
Herbal and traditional medicines require regulatory documentation before marketing.
We provide regulatory support including:
• Herbal product regulatory dossiers
• Ingredient safety documentation
• Product technical documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products must comply with EU Cosmetic Regulation–aligned requirements before marketing in Turkey.
Our services include:
• Cosmetic Product Information File (PIF) preparation
• Cosmetic safety assessment documentation
• Ingredient regulatory compliance verification
• Cosmetic product notification documentation
Veterinary Products
• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical scientific document writing
• Product development documentation
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Turkey
Turkey Market Entry Support
Our regulatory experts assist companies seeking to enter the Turkish pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD / eCTD dossier development
• TİTCK regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Turkey TİTCK regulatory requirements
✔ ICH and EU-aligned regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.