Global Product Development Report (PDR) Services – Pharma
For Pharmaceutical Companies in Oman
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, importers, distributors, and marketing authorization holders in Oman.
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 health authorities.
Importance of PDR for Oman Pharma Companies
For pharmaceutical companies operating in Oman, a scientifically robust Product Development Report (PDR) is essential for:
Ministry of Health (MOH) Oman product registration
Technical evaluation of quality, formulation & development rationale
Import licensing, renewals & post-approval variations
GCC market access and regional registrations
Readiness for WHO, PIC/S & international GMP inspections
ProdDev delivers science-driven, MOH-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 & import readiness
Our Core PDR Services – Pharma (Oman 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 & optimization studies
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 & MOH Oman 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 MOH Oman / Health Authority development-related queries
Scientific justification for development-related deficiencies
Post-submission & post-approval 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 line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD dossier structure
WHO Technical Report Series (TRS)
MOH Oman regulatory requirements
GCC, EU, ASEAN, LATAM & ROW frameworks
This ensures Oman-registered and imported products meet regional and global expectations.
Industries We Serve in Oman
Pharmaceutical manufacturers & importers
Marketing Authorization Holders (MAHs)
Export-oriented pharma companies
Contract Development & Manufacturing Organizations (CDMOs)
Regulatory affairs & compliance consultancies
Why Oman Pharma Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong GCC & Middle East regulatory experience
✅ MOH-aligned, inspection-ready documentation
✅ Integrated R&D, QA & Regulatory expertise
✅ 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:
Oman | GCC | Middle East | Africa | Europe | Asia | LATAM
From local MOH submissions to regional GCC and global 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 – Oman PDR Specialists
Looking for PDR Protocol & Report preparation, review, or MOH Oman regulatory query support for your pharmaceutical product in Oman?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.