ProdDev – Global Product Development Report (PDR) Services for the United Arab Emirates
MOHAP-Aligned | GCC-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 based in the United Arab Emirates—a rapidly expanding GCC pharmaceutical manufacturing, trading, and re-export hub—supporting UAE national registrations and multi-country GCC & global regulatory submissions.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, MAHs, CDMOs, and regulatory teams worldwide, ensuring scientific robustness, regulatory compliance, and authority acceptance.
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 regulated and semi-regulated markets.
Our multidisciplinary team includes:
Pharmaceutical formulation & development scientists
GCC & international regulatory affairs professionals
QA & GMP compliance experts
Technical documentation specialists
We bridge the gap between:
Formulation & CMC development → Scale-up → Regulatory submission
R&D and manufacturing data → Authority-acceptable documentation
Development stage → Commercial & GCC export readiness
Our Core PDR Services – UAE (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with QbD-aligned justification
Development rationale for QTPP, CQA, CMA & CPP
Comparative formulation & process development studies
Excipient selection & compatibility justification
Scale-up, tech transfer & manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD & MOHAP / GCC expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to minimize regulatory deficiencies
📊 Backup Data Compilation & Presentation
Comprehensive development backup data compilation
Lab-scale, pilot-scale & exhibit/registration batch summaries
Dissolution development & comparative profiles
Stability development data aligned with ICH climatic Zone IVb
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
MOHAP / GCC-DR / US FDA / EMA / WHO PDR-related query responses
Scientific justification for formulation, QbD, scale-up & stability observations
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)
Regulatory Alignment for the United Arab Emirates
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
MOHAP (UAE) quality & CMC requirements
GCC Drug Registration (GCC-DR) framework
PIC/S & WHO TRS principles
Export-market requirements (EU, UK, US, Africa & LATAM)
We ensure documentation meets UAE & GCC authority expectations while remaining globally acceptable.
Industries We Serve in the UAE
Pharmaceutical finished dosage manufacturers
Local & regional generic pharma companies
Export-oriented & re-export businesses
Contract Manufacturing Organizations (CMOs & CDMOs)
Marketing Authorization Holders (MAHs)
The UAE’s role as a regional regulatory gateway for the Middle East & Africa requires inspection-ready, authority-focused development documentation—this is where ProdDev delivers consistent value.
Why UAE-Based Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with MOHAP & GCC submissions
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & regulatory expertise
✅ End-to-end lifecycle & authority query support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product & target-market understanding
UAE / GCC & global regulatory 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 UAE-based companies supplying to:
United Arab Emirates | GCC | Middle East | Africa | EU | UK | US | LATAM
Our PDRs are designed to be inspection-ready, regulator-friendly, and submission-acceptable across global markets.
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 UAE-manufactured or UAE-registered pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.