ProdDev – Global Product Development Report (PDR) Services for Afghanistan
MoPH-Aligned | Import & Registration-Ready | Globally Trusted
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 supplying to Afghanistan—supporting product registration, import approval, and regulatory compliance for finished pharmaceutical products manufactured locally or imported into Afghanistan.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, MAHs, and regulatory teams across Asia, Middle East, Africa, Europe, and LATAM, ensuring scientific accuracy, regulatory acceptability, and authority readiness.
Who We Are
ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol & Report preparation, independent review, and lifecycle regulatory support for regulated and semi-regulated markets.
Our expert team includes:
Pharmaceutical formulation & development scientists
International regulatory affairs professionals
QA & GMP compliance experts
Technical documentation specialists
We bridge the gap between:
Formulation development → Scale-up → Regulatory submission
R&D and manufacturing data → Authority-acceptable documentation
Development stage → Market authorization & import readiness
Our Core PDR Services – Afghanistan (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with clear formulation rationale
Development justification for QTPP, CQAs, CMAs & CPPs
Comparative formulation & process development summaries
Excipient selection & compatibility justification
Manufacturing process & scale-up readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against Afghanistan MoPH / GDPA requirements
Identification of documentation gaps & risk areas
Authority-focused restructuring to improve acceptance
📊 Backup Data Compilation & Presentation
Compilation of development & supportive data
Lab-scale & pilot-scale development summaries
Dissolution development & comparative profiles
Stability development data (ICH-referenced, country-acceptable)
Process understanding & control summaries
📨 Regulatory Query Handling (Post-Submission)
Afghanistan Ministry of Public Health (MoPH) query responses
Scientific justification for formulation & development-related deficiencies
Support during registration review cycles
PDR updates for renewals & variations
Dosage Forms We Support
Tablets (IR, MR)
Capsules (Hard gelatin)
Oral liquids & suspensions
Powders & granules
Topical & semi-solid formulations
Fixed Dose Combinations (FDCs)
Regulatory Alignment for Afghanistan
Our PDRs are prepared in alignment with:
ICH Guidelines (Q8, Q9, Q10 – as applicable)
CTD-based quality documentation principles
Afghanistan MoPH / GDPA import & registration requirements
WHO Technical Report Series (TRS) references
Export-country GMP & stability justification standards
We ensure documentation is practical, authority-focused, and suitable for Afghanistan’s regulatory framework.
Industries We Serve in Afghanistan
Pharmaceutical importers & distributors
Generic medicine suppliers
Contract manufacturers exporting to Afghanistan
Brand owners & Marketing Authorization Holders (MAHs)
NGOs & institutional medicine suppliers
Afghanistan’s market requires clear, scientifically justified, and regulator-friendly documentation—this is where ProdDev delivers consistent value.
Why Companies Supplying to Afghanistan Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience in semi-regulated & emerging markets
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & regulatory expertise
✅ Support for imports, registrations & renewals
✅ Strict confidentiality & data integrity
Our Structured Approach
Product & Afghanistan market understanding
MoPH regulatory requirement mapping
PDR Protocol preparation / review
Scientific PDR Report writing with supportive data
Independent QA & regulatory review
Submission-ready delivery & query support
Who We Work With
We support companies supplying pharmaceuticals to:
Afghanistan | Central Asia | Middle East | Africa
Our PDRs are designed to be clear, compliant, and authority-acceptable, minimizing approval delays.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality agreements
Data integrity principles
GMP-aligned documentation practices
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for pharmaceutical products supplied to Afghanistan?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.