Global Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP)

PharmaTechXfer

Global Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP)

Regulatory-Compliant | Authority-Ready | 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 worldwide.

Since 2008, we have successfully supported 150+ FDP tech transfer projects across Asia, Middle East, Africa, Europe, and LATAM, ensuring smooth scale-up, regulatory compliance, and commercial manufacturing readiness.

Who We Are

PharmaTechXfer is a specialized pharmaceutical technology transfer service provider, focused exclusively on FDP Tech Transfer documentation, execution support, and regulatory query handling.

Our services bridge the gap between:

• R&D → Pilot → Commercial manufacturing

• Sending site → Receiving site

• Development → Regulatory approval → Commercial supply

All activities are performed by experienced pharmaceutical technologists, QA experts, and regulatory professionals, ensuring GMP-compliant, authority-acceptable 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)

• Process control strategy & CPP/CQA mapping

• Equipment equivalency & scale-up justification

• Packaging & labeling transfer documentation

🏭 Manufacturing & Process Transfer Support

• R&D to commercial scale transfer

• Site-to-site technology transfer

• Equipment mapping & process optimization

• Scale-up and validation readiness support

• Risk assessment (ICH Q9-based)

📑 Regulatory-Aligned Tech Transfer

• Tech Transfer documents aligned with CTD / eCTD Module 3

• Country-specific compliance (MOH / FDA / EMA expectations)

• Support for ANDA, MAA, variations & site change submissions

• Tech Transfer documentation for inspections & audits

🛡️ Post-Transfer & Operational Support

• Handling MOH / FDA queries related to tech transfer

• Deficiency response preparation & scientific justification

• Change control documentation

• Post-approval variation support

• Inspection readiness assistance

Dosage Forms We Support

• Tablets (IR, MR, ER, EC)

• Capsules (Hard gelatin & HPMC)

• Oral liquids & suspensions

• Dry syrups

• Powders & granules

• Semi-solids (where applicable)

Industries & Clients We Serve

• Pharmaceutical manufacturers

• Contract Manufacturing Organizations (CMOs)

• API-to-FDP expansion companies

• Global exporters & brand owners

• Regulatory submission holders

Global Regulatory Coverage

Our Tech Transfer services comply with requirements of:

• Asia

• Middle East (GCC)

• Africa

• Europe

• Latin America (LATAM)

• ROW markets

Aligned with:

• ICH Guidelines (Q8, Q9, Q10)

• WHO GMP

• US FDA

• EU GMP

• Country-specific MOH requirements

Why PharmaTechXfer?

✅ 150+ FDP Tech Transfer projects completed
✅ Since 2008 global regulatory experience
✅ Authority-ready documentation
✅ End-to-end lifecycle support
✅ Strong post-operation query 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 strategy

4. GMP & regulatory-aligned documentation

5. Post-transfer support until 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 regulated and semi-regulated markets.

“PharmaTechXfer – Global FDP Technology Transfer, Done Right”

Excellence in FDP Technology Transfer Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Tech Transfer Services (FDP)

1. What is Technical Transfer (Tech Transfer) in Finished Dosage Products (FDP)?

Technical Transfer in FDP is a structured process of transferring product knowledge, manufacturing processes, analytical methods, and quality controls from one site to another (R&D to commercial or site-to-site) to ensure consistent, reproducible, and GMP-compliant production.

2. What types of Tech Transfer services does PharmaTechXfer provide?

PharmaTechXfer provides end-to-end FDP Tech Transfer services, including:

• Tech Transfer documentation

• Manufacturing process transfer

• Scale-up & equipment equivalency support

• Regulatory-aligned Tech Transfer dossiers

• Post-transfer query handling with MOH / FDA

3. Which dosage forms are covered under your Tech Transfer services?

We support a wide range of Finished Dosage Forms, including:

• Tablets (IR, MR, ER, EC)

• Capsules (Hard gelatin & HPMC)

• Oral liquids & suspensions

• Dry syrups

• Powders & granules

4. Do you provide Tech Transfer services for international markets?

Yes. We provide global Tech Transfer support in compliance with Asia, Middle East, Africa, Europe, LATAM, and ROW regulatory requirements, aligned with ICH, WHO, US FDA, and EU GMP guidelines.

5. How many Tech Transfer projects has PharmaTechXfer handled?

We have successfully completed 150+ FDP Tech Transfer projects globally since 2008, covering multiple dosage forms and regulatory markets.

6. Do you support R&D to commercial scale Tech Transfer?

Yes. We specialize in:

• R&D → Pilot → Commercial scale transfer

• Scale-up strategy development

• Process optimization and control strategy definition

• Validation readiness support

7. Can you assist with site-to-site Tech Transfer?

Absolutely. We provide sending site to receiving site Tech Transfer, including:

• Gap assessment

• Equipment mapping

• Process comparability & risk assessment

• Transfer protocol and execution support

8. Are your Tech Transfer documents suitable for regulatory submissions?

Yes. All Tech Transfer documentation is prepared to be CTD / eCTD Module 3 aligned and is suitable for:

• ANDA / MAA submissions

• Site change variations

• Post-approval changes

• Regulatory inspections & audits

9. Do you handle regulatory authority queries related to Tech Transfer?

Yes. We provide complete post-operation support, including:

• MOH / FDA query responses

• Scientific justifications

• Deficiency letters & variation responses

• Inspection observations related to Tech Transfer

10. Can you customize Tech Transfer documentation as per country-specific requirements?

Yes. All documentation is customized based on:

• Target country regulations

• Dosage form & process complexity

• Manufacturing site capabilities

• Authority expectations

11. What is the typical timeline for FDP Tech Transfer projects?

Timelines vary depending on:

• Dosage form

• Scale of transfer

• Regulatory market

• Site readiness
  Typically, documentation preparation ranges from 4–8 weeks, with execution support continuing as per project scope.

12. Do you support validation and commercial production readiness?

Yes. We provide validation-ready documentation and support for:

• Process validation

• Cleaning validation interface

• Continued process verification (CPV) alignment

13. Who should engage PharmaTechXfer services?

Our services are ideal for:

• Pharmaceutical manufacturers

• CMOs / CDMOs

• API manufacturers entering FDP

• Exporters & brand owners

• Companies undergoing site changes or scale-up

14. How do we initiate a Tech Transfer project with PharmaTechXfer?

You can contact us via email or phone, share basic product and site details, and our team will provide:

• Scope definition

• Timelines

• Commercial proposal

• Project execution plan

15. Why choose PharmaTechXfer over generic consultants?

Because PharmaTechXfer offers:

• Specialized FDP Tech Transfer expertise

• Regulator-focused documentation

• Proven global experience

• Strong post-transfer authority query handling

• Practical, inspection-ready approach