PharmaTechXfer Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP) – Georgia

MoH / SRAMA-Compliant | WHO & EU 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 localization partners supplying the Georgian market.

Since 2008, we have successfully supported 150+ FDP technology transfer projects across Eastern Europe, CIS, Asia, Middle East, Africa, and Latin America, including projects aligned with the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia (MoH) and the LEPL State Regulation Agency for Medical Activities (SRAMA), in line with WHO / EU GMP expectations—ensuring smooth localization, regulatory approval, and inspection-ready commercial manufacturing in Georgia.

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 Georgia, we act as a technical and regulatory bridge between:

  • R&D → Pilot → Commercial manufacturing

  • Sending site (EU / global originator) → Receiving site (Georgia / regional hub)

  • Product development → MoH / SRAMA approval → National & regional supply

All services are delivered by experienced pharmaceutical technologists, QA professionals, and regulatory experts, ensuring GMP-compliant, authority-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)

  • CPP / CQA mapping and control strategy

  • Equipment equivalency, scale-up & site suitability justification

  • Packaging & labeling technology transfer documentation (Georgian/Russian/English alignment where required)

🏭 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 (Georgia Focus)

  • Tech Transfer documentation aligned with CTD / eCTD Module 3

  • Compliance with Georgia MoH / SRAMA, WHO GMP, and EU GMP expectations

  • Support for:

    • New product registrations & localization dossiers

    • Manufacturing site change / site addition approvals

    • Post-approval variations & lifecycle management

    • Import substitution and local production initiatives

  • Tech Transfer documentation for authority reviews & GMP inspections

🛡️ Post-Transfer & Operational Support

  • Handling MoH / SRAMA authority queries related to technology transfer

  • Deficiency response preparation with strong scientific justification

  • Change control & variation 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 Georgia

  • Pharmaceutical manufacturers

  • Local and regional CMOs / CDMOs

  • Marketing Authorization Holders (MAHs)

  • Multinational companies pursuing localization strategies

  • Export-oriented companies supplying CIS & Eastern Europe

Georgia & Global Regulatory Alignment

Our Tech Transfer services are designed to meet Georgia regulatory requirements while remaining fully aligned with international standards, including:

  • Georgia Ministry of Health

  • LEPL State Regulation Agency for Medical Activities (SRAMA)

  • WHO GMP

  • EU GMP

  • ICH Guidelines (Q8, Q9, Q10)

Why Clients Serving Georgia Choose PharmaTechXfer

✅ 150+ FDP Tech Transfer projects completed
✅ Since 2008 CIS & Eastern Europe regulatory experience
✅ MoH/SRAMA & WHO/EU GMP-aligned documentation
✅ End-to-end tech transfer lifecycle support
✅ Strong authority query & variation handling
✅ Proven, inspection-friendly approach

Our Approach

Scientific. Structured. Regulator-Focused.

  1. Product & process understanding

  2. Gap analysis between sending & receiving site

  3. Customized Tech Transfer & localization strategy

  4. GMP & authority-aligned documentation

  5. 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 CIS, Eastern Europe, Europe, Asia, Africa, and Middle East, including Georgia.