ProdDev – Global Product Development Report (PDR) Services for China
China
Internationally Aligned | Export-Driven | Authority-Ready
ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) Protocol & Report preparation and review services for pharmaceutical companies based in China—one of the world’s largest hubs for APIs, intermediates, finished dosage forms, and global pharmaceutical exports—supporting international regulatory submissions across regulated and semi-regulated markets.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, CDMOs, and regulatory teams worldwide, enabling approvals across US, EU, UK, ASEAN, GCC, Africa, CIS & LATAM.
Who We Are
ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol & Report preparation, independent technical review, and full lifecycle regulatory support for global markets.
Our multidisciplinary team includes:
Pharmaceutical formulation & development scientists
International regulatory affairs professionals
QA & GMP compliance experts
Technical documentation specialists
We bridge the gap between:
R&D & formulation development → Scale-up → Global regulatory submission
CMC & development data → Authority-acceptable documentation
Manufacturing readiness → International market access
Our Core PDR Services – China (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation for export dossiers
Scientific PDR Report writing with strong development rationale
Justification for QTPP, CQA, CMA & CPP (QbD-aligned)
Comparative formulation & process development studies
Excipient selection & compatibility justification
Scale-up, tech transfer & commercial manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD & target-market authority expectations
Identification of compliance risks for US/EU/WHO/ASEAN markets
Authority-focused restructuring to minimize regulatory deficiencies
📊 Backup Data Compilation & Presentation
Complete development backup data compilation
Lab-scale, pilot-scale & exhibit/registration batch summaries
Dissolution method development & comparative profiles
Stability development data aligned with ICH climatic zones
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
US FDA / EU / UK MHRA / WHO / MOH query responses related to PDR
Scientific justification for formulation, QbD, scale-up & stability issues
Post-submission & post-approval lifecycle support
PDR updates for variations, renewals & site changes
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 for Chinese Manufacturers
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
US FDA, EMA, UK MHRA
WHO Prequalification & PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
We ensure PDRs meet international expectations beyond local Chinese requirements, enabling smoother approvals in export markets.
Industries We Serve in China
API & intermediate manufacturers
Finished dosage manufacturers
Export-oriented pharmaceutical companies
Contract Development & Manufacturing Organizations (CDMOs)
International MAHs & regulatory consultants
China’s scale, complexity, and export reach demand globally consistent, inspection-ready development documentation—this is where ProdDev delivers measurable value.
Why China-Based Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with export-focused development documentation
✅ Authority-ready, science-driven PDRs
✅ Integrated R&D, QA & international regulatory expertise
✅ End-to-end lifecycle & regulatory query support
✅ Strict confidentiality & data integrity controls
Our Structured Approach
Product & target-market understanding
Global regulatory & development requirement mapping
PDR Protocol preparation / critical review
Scientific PDR Report writing with complete backup data
Independent QA & regulatory review
Submission-ready delivery & post-submission support
Who We Work With
We support China-based companies supplying to:
US | EU | UK | ASEAN | GCC | Africa | CIS | LATAM
Our PDRs are designed to be inspection-ready, regulator-friendly, and globally submission-acceptable.
Confidentiality & Compliance
All projects are executed under strict:
Confidentiality agreements
Data integrity principles (ALCOA+)
GMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your China-manufactured pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd