PharmaTechXfer Global Technical Transfer (Tech Transfer) Services for Finished Dosage Products (FDP) – Peru
Regulatory-Compliant | DIGEMID-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 and marketing authorization holders in Peru, supporting both local commercialization and international exports.
Since 2008, we have successfully completed 150+ FDP technology transfer projects across Asia, Middle East, Africa, Europe, and Latin America, 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 Finished Dosage Form (FDP) Tech Transfer documentation, execution support, and regulatory query handling.
We help Peruvian companies seamlessly bridge the gap between:
R&D → Pilot → Commercial manufacturing
Sending site → Receiving site
Product development → Regulatory approval → Commercial supply
All activities are carried out by experienced pharmaceutical technologists, QA professionals, and regulatory experts, ensuring GMP-compliant and 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 with CPP / CQA mapping
Equipment equivalency studies & scale-up justification
Packaging & labeling transfer documentation
🏭 Manufacturing & Process Transfer Support
R&D to commercial scale transfer
Site-to-site technology transfer (local & overseas)
Equipment mapping & process optimization
Scale-up & validation readiness support
Risk assessment aligned with ICH Q9
📑 Regulatory-Aligned Tech Transfer (Peru Focus)
Tech Transfer documentation aligned with CTD / eCTD – Module 3
Compliance with DIGEMID (Peru Ministry of Health) requirements
Support for:
Product registration & renewal
Manufacturing site changes & technology transfer filings
Variations and post-approval changes
Export dossiers for LATAM & global markets
Tech Transfer documentation support for DIGEMID inspections & audits
🛡️ Post-Transfer & Operational Support
Handling DIGEMID and overseas authority queries related to tech transfer
Scientific deficiency response preparation
Change control documentation
Post-approval variation support
Inspection & 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 Peru
Pharmaceutical manufacturers
Contract Manufacturing Organizations (CMOs)
Importers & local distributors
API manufacturers expanding into FDP
Marketing Authorization Holders (MAHs)
Export-oriented pharmaceutical companies
Global Regulatory Coverage
Our Tech Transfer services support Peru-based companies supplying to:
Latin America (LATAM)
Andean Community (CAN)
Central America & Caribbean
Africa
Middle East
Asia & ROW markets
Aligned with:
ICH Guidelines (Q8, Q9, Q10)
WHO GMP
US FDA
EU GMP
Country-specific Ministry of Health requirements
Why PharmaTechXfer?
✅ 150+ FDP Tech Transfer projects completed
✅ Since 2008 global regulatory experience
✅ Authority-ready & inspection-friendly documentation
✅ End-to-end lifecycle support
✅ Strong post-submission query handling
✅ Proven success in regulated & semi-regulated markets
Our Approach
Scientific. Structured. Regulator-Focused.
Product & process understanding
Gap analysis between sending & receiving sites
Customized Tech Transfer strategy
GMP & regulatory-aligned documentation
Post-transfer support until commercial 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 worldwide.