PharmaTechXfer Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP) – Turkey
TİTCK-Compliant | EU, PIC/S & WHO GMP Aligned | Globally Trusted
PharmaTechXfer, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP) to pharmaceutical manufacturers, MAHs, and global partners serving the Turkish market.
Since 2008, we have successfully supported 150+ FDP technology transfer projects across Europe, Middle East, Asia, Africa, and Latin America, including projects aligned with Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) requirements and EU/PIC/S-aligned GMP expectations—ensuring smooth technology transfer, regulatory acceptance, and inspection-ready commercial manufacturing in Turkey.
Who We Are
PharmaTechXfer is a specialized pharmaceutical technology transfer consulting partner, focused exclusively on Finished Dosage Product (FDP) Tech Transfer documentation, execution support, and regulatory query handling.
For companies manufacturing in or supplying to Turkey, we act as a technical and regulatory bridge between:
R&D → Pilot → Commercial manufacturing
Sending site (EU / overseas) → Receiving site (Turkey)
Product development → TİTCK approval → Domestic & EU-aligned supply
All services are delivered by experienced pharmaceutical technologists, QA professionals, and regulatory experts, ensuring GMP-compliant, TİTCK-acceptable, and inspection-ready technology transfer.
Our Core Tech Transfer Services (FDP)
🔬 Technical Transfer Documentation
Product & process knowledge transfer dossiers
Detailed manufacturing process descriptions & flow diagrams
Master Formula Records (MFR) & Batch Manufacturing Records (BMR)
Critical Process Parameters (CPP) & Critical Quality Attributes (CQA) mapping
Equipment equivalency, scale-up & site suitability justification
Packaging & labeling technology transfer documentation (TR/EU alignment)
🏭 Manufacturing & Process Transfer Support
R&D to commercial scale technology transfer
Originator-to-local / site-to-site technology transfer
Equipment mapping, process optimization & line qualification
Scale-up support and process validation readiness
Quality Risk Management as per ICH Q9
📑 Regulatory-Aligned Tech Transfer (Turkey Focus)
Tech Transfer documentation aligned with CTD / eCTD Module 3
Compliance with TİTCK, EU GMP, PIC/S GMP, and WHO GMP requirements
Support for:
New product registrations (generic / hybrid)
Manufacturing site change / site addition approvals
Post-approval variations & lifecycle management
Localization and EU-bridging dossiers
Tech Transfer documentation for TİTCK inspections & GMP audits
🛡️ Post-Transfer & Operational Support
Handling TİTCK / authority queries related to technology transfer
Deficiency response preparation with strong scientific justification
Change control documentation
Post-approval variation support
Pre-inspection and audit readiness assistance
Dosage Forms We Support
Tablets (IR, MR, ER, EC)
Capsules (Hard gelatin & HPMC)
Oral liquids & suspensions
Dry syrups
Powders & granules
Semi-solid dosage forms (where applicable)
Industries & Clients We Serve in Turkey
Pharmaceutical manufacturers
Contract Manufacturing Organizations (CMOs / CDMOs)
Marketing Authorization Holders (MAHs)
Local and multinational brand owners
Companies pursuing localization & EU-aligned production
Turkey & Global Regulatory Alignment
Our Tech Transfer services are designed to meet Turkey TİTCK requirements while remaining fully aligned with international regulatory standards, including:
Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK)
EU GMP
PIC/S GMP
WHO GMP
ICH Guidelines (Q8, Q9, Q10)
Why Clients Serving Turkey Choose PharmaTechXfer
✅ 150+ FDP Tech Transfer projects completed
✅ Since 2008 EU, Middle East & global regulatory experience
✅ TİTCK & EU GMP-aligned documentation
✅ End-to-end tech transfer lifecycle support
✅ Strong regulatory query & deficiency handling
✅ Proven, inspection-friendly approach
Our Approach
Scientific. Structured. Regulator-Focused.
Comprehensive product & process understanding
Gap analysis between sending & receiving site
Customized Tech Transfer & regulatory strategy
GMP & TİTCK-aligned documentation
Post-transfer support until process stabilization
About Zoesoe Exports Pvt. Ltd.
PharmaTechXfer operates as a scientific arm of Zoesoe Exports Pvt. Ltd., a globally trusted pharmaceutical consulting and technical services organization supporting manufacturers across EU, Middle East, Asia, Africa, and regulated global markets, including Turkey