Global Product Development Report (PDR) Services – Pharma

For Pharmaceutical Companies in Qatar

Regulatory-Compliant | Authority-Ready | Globally Trusted

ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., delivers 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 Qatar.

Since 2008, we have prepared and reviewed 600+ PDRs for pharmaceutical companies across Asia, Middle East, Africa, Europe, and LATAM, ensuring technical accuracy, regulatory compliance, and smooth acceptance by health authorities.

Why PDR Matters for Qatar Pharma Companies

For companies operating in Qatar, a robust Product Development Report (PDR) is essential for:

  • Ministry of Public Health (MoPH) Qatar product registration

  • Technical evaluation of quality, formulation & development rationale

  • Import licensing, renewals & post-approval variations

  • GCC regional registrations and harmonized submissions

  • Readiness for WHO, PIC/S & international GMP inspections

ProdDev provides science-driven, MoPH-aligned, and globally acceptable PDR documentation.

Who We Are

ProdDev is a specialized pharmaceutical development documentation provider, focused exclusively on:

  • PDR Protocol preparation

  • PDR Report writing & independent review

  • Product development lifecycle & regulatory support

Our Multidisciplinary 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 (Qatar 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 & MoPH Qatar 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 MoPH Qatar / Health Authority development-related queries

  • Scientific justification for 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)

  • MoPH Qatar regulatory requirements

  • GCC, EU, ASEAN, LATAM & ROW frameworks

This ensures Qatar-registered and imported products meet regional and global expectations.

Industries We Serve in Qatar

  • Pharmaceutical manufacturers & importers

  • Marketing Authorization Holders (MAHs)

  • Export-oriented pharma companies

  • Contract Development & Manufacturing Organizations (CDMOs)

  • Regulatory affairs & compliance consultancies

Why Qatar Pharma Companies Choose ProdDev

600+ PDRs successfully prepared & reviewed
✅ Strong GCC & Middle East regulatory experience
MoPH-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

  1. Product understanding & scope finalization

  2. Regulatory & development requirement mapping

  3. PDR protocol preparation / review

  4. Scientific PDR report writing with backup data

  5. Independent QA & regulatory review

  6. Submission-ready delivery & authority query support

Who We Work With

We support pharmaceutical clients across:

Qatar | GCC | Middle East | Africa | Europe | Asia | LATAM

From local MoPH submissions to regional GCC and global registrations, our PDRs are designed to be authority-ready and inspection-acceptable.

Confidentiality & Compliance

All projects are managed under strict:

  • Confidentiality agreements

  • Data integrity principles

  • GMP & international regulatory compliance standards

Get in Touch – Qatar PDR Specialists

Looking for PDR Protocol & Report preparation, review, or MoPH Qatar regulatory query support for your pharmaceutical product in Qatar?

📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.