Global Product Development Report (PDR) Services – Pharma
For Pharmaceutical Companies in China
Regulatory-Compliant | Authority-Ready | Globally Trusted
ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) Protocol & Report preparation, review, and regulatory support services for pharmaceutical manufacturers, exporters, and marketing authorization holders in China.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical companies across Asia, Middle East, Africa, Europe, and LATAM, ensuring technical accuracy, regulatory compliance, and smooth acceptance by global health authorities.
Importance of PDR for China Pharma Companies
For pharmaceutical companies in China, a robust Product Development Report (PDR) is a critical technical document for:
NMPA (China FDA) submissions & technical reviews
Export registrations to regulated & semi-regulated markets
CTD / eCTD-based dossier preparation
WHO-GMP, PIC/S & international inspections
Technology transfer, scale-up & lifecycle management
ProdDev delivers science-driven, NMPA-aligned, and globally acceptable PDR documentation.
Who We Are
ProdDev is a specialized pharmaceutical development documentation service provider, focused exclusively on:
PDR Protocol preparation
PDR Report writing & independent review
Product development lifecycle & regulatory support
Our Expert Team
Pharmaceutical formulation scientists
Regulatory affairs professionals
QA & GMP experts
Technical documentation specialists
We bridge the gap between:
Formulation development → Scale-up → Regulatory approval
R&D data → Authority-acceptable documentation
Development stage → Commercial & export readiness
Our Core PDR Services – Pharma (China Focused)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
PDR Report writing with strong scientific justification
Development rationale for QTPP, CQA, CMA & CPP
Comparative development studies & optimization data
Excipient selection & compatibility justification
Scale-up and manufacturing readiness justification
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD & NMPA expectations
Risk identification with corrective recommendations
Authority-focused restructuring of PDR content
📊 Backup Data Compilation & Presentation
Compilation of complete development backup data
Lab-scale, pilot-scale & exhibit batch data
Dissolution development & comparative profiles
Stability development data (where applicable)
Process optimization & robustness studies
📨 Regulatory Query Handling (Post-Submission)
Responses to NMPA / MOH / Health Authority development-related queries
Scientific justification for deficiencies
Post-submission & post-inspection support
Lifecycle updates to PDR documentation
Dosage Forms We Support
Tablets (IR, MR, ER, DR)
Capsules (Hard gelatin, HPMC)
Oral liquids & suspensions
Powders & granules
Topical & semi-solid formulations
Sterile & non-sterile products (documentation support)
Fixed Dose Combinations (FDCs)
Global Regulatory Alignment
Our PDR documents are prepared in accordance with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD dossier formats
WHO Technical Report Series (TRS)
NMPA China regulatory expectations
EU, ASEAN, GCC, LATAM & ROW frameworks
This enables China-manufactured products to achieve global regulatory acceptance.
Industries We Serve in China
Pharmaceutical finished dosage manufacturers
API & finished product exporters
Contract Development & Manufacturing Organizations (CDMOs)
Regulatory affairs & compliance consultancies
Brand owners & marketing authorization holders
Why China Pharma Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Proven experience with China exports & global registrations
✅ NMPA-aligned, inspection-ready documentation
✅ Strong integration of R&D, QA & Regulatory
✅ End-to-end product development lifecycle support
✅ Confidential, reliable & deadline-driven execution
Our Structured PDR Approach
Product understanding & scope finalization
Regulatory & development requirement mapping
PDR protocol preparation / review
Scientific PDR report writing with backup data
Independent QA & regulatory review
Submission-ready delivery & authority query support
Who We Work With
We support pharmaceutical clients across:
China | Asia | Middle East | Africa | Europe | LATAM
From local NMPA submissions to international registrations, our PDRs are designed to be authority-ready and inspection-acceptable.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality agreements
Data integrity principles
GMP & international regulatory compliance standards
Get in Touch – China PDR Specialists
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your pharmaceutical product in China?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.