PharmaTechXfer Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP) – Sri Lanka
NMRA-Compliant | 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 regional partners serving the Sri Lankan market.
Since 2008, we have successfully supported 150+ FDP technology transfer projects across Asia, Middle East, Africa, Europe, and Latin America, including projects aligned with National Medicines Regulatory Authority (NMRA), Sri Lanka and WHO GMP expectations, ensuring smooth technology transfer, regulatory acceptance, and uninterrupted commercial supply.
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 Sri Lanka, we act as a technical and regulatory bridge between:
R&D → Pilot → Commercial manufacturing
Sending site (India / regional / overseas) → Receiving site
Product development → NMRA approval → National & institutional supply
All services are delivered by experienced pharmaceutical technologists, QA professionals, and regulatory experts, ensuring GMP-compliant, NMRA-acceptable, and inspection-ready technology transfer.
Our Core Tech Transfer Services (FDP)
🔬 Technical Transfer Documentation
Product & process knowledge transfer dossiers
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 justification
Packaging & labeling technology transfer documentation
🏭 Manufacturing & Process Transfer Support
R&D to commercial scale technology transfer
Site-to-site technology transfer (South Asia & global sites)
Equipment mapping, line suitability & process optimization
Scale-up support and process validation readiness
Quality Risk Management as per ICH Q9
📑 Regulatory-Aligned Tech Transfer (Sri Lanka Focus)
Tech Transfer documentation aligned with CTD / eCTD Module 3
Compliance with NMRA Sri Lanka, WHO GMP, and regional regulatory expectations
Support for:
New product registration dossiers
Manufacturing site change / site addition approvals
Post-approval variations & lifecycle management
Institutional and tender-based supply dossiers
Tech Transfer documentation for NMRA inspections & GMP audits
🛡️ Post-Transfer & Operational Support
Handling NMRA / authority queries related to technology transfer
Deficiency response preparation with 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 Sri Lanka
Pharmaceutical manufacturers
Importers and Marketing Authorization Holders (MAHs)
Regional CMOs and partner manufacturing sites
Export-oriented companies supplying Sri Lanka
Government and institutional supply partners
Sri Lanka & Global Regulatory Alignment
Our Tech Transfer services are designed to meet Sri Lanka NMRA requirements while remaining fully aligned with international regulatory standards, including:
National Medicines Regulatory Authority (Sri Lanka)
WHO GMP
ICH Guidelines (Q8, Q9, Q10)
Regional MOH expectations
Export market compliance (where applicable)
Why Clients Supplying Sri Lanka Choose PharmaTechXfer
✅ 150+ FDP Tech Transfer projects completed
✅ Since 2008 South Asia & global regulatory experience
✅ NMRA & WHO 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.
Product & process understanding
Gap analysis between sending & receiving site
Customized Tech Transfer strategy
GMP & NMRA-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 South Asia, ASEAN, Middle East, Africa, and global markets, including Sri Lanka
