ProdDev – Global Product Development Report (PDR) Services for Asia

Regulatory-Compliant | Authority-Ready | Asia Market Focused

ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) documentation and review services for pharmaceutical products intended for Asian regulatory markets.

Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, and regulatory teams supplying to Asia’s regulated and emerging markets, ensuring technical accuracy, regulatory compliance, and authority acceptance.

Who We Are

ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol and PDR Report preparation, review, and lifecycle support.

Our multidisciplinary team includes:

• Pharmaceutical formulation scientists
• Regulatory affairs professionals
• QA & GMP experts
• Technical documentation specialists

We bridge the gap between:

• Formulation development → Scale-up → Regulatory submission
• R&D experimental data → Regulatory-acceptable documentation
• Development stage → Commercial manufacturing readiness

Our Core PDR Services – Asia Pharma

📘 Product Development Report (PDR) Documentation

• Complete PDR Protocol preparation
• Scientific PDR Report writing with technical justification
• Development rationale for QTPP, CQA, CMA & CPP
• Comparative development studies and formulation optimization
• Excipient selection & compatibility justification
• Scale-up and manufacturing readiness justification

🔍 PDR Review & Gap Assessment

• Independent technical and regulatory review of existing PDRs
• Gap assessment against ICH, CTD, and Asian regulatory guidelines
• Identification of development risks and corrective recommendations
• Authority-focused restructuring of PDR documentation

📊 Development Data Compilation & Presentation

• Compilation of complete development backup data

Including:

• Lab-scale and pilot-scale development batches
• Exhibit / registration batch data
• Dissolution development & comparative profiles
• Stability development studies
• Process optimization and robustness data

📨 Regulatory Query Support

• MOH / Drug Authority queries related to product development

Support includes:

• Scientific justification for development-related queries
• Post-submission query response preparation
• Inspection support documentation
• Lifecycle updates to PDR documentation

Dosage Forms We Support

• Tablets (IR, MR, ER, DR)
• Capsules (Hard gelatin, HPMC)
• Oral liquids & suspensions
• Powders & granules
• Topical and semi-solid formulations
• Sterile and non-sterile dosage forms (documentation support)
• Fixed Dose Combinations (FDCs)

Asian Regulatory Alignment

Our PDR documentation is aligned with major Asian regulatory frameworks, including:

• Association of Southeast Asian Nations (ASEAN) CTD requirements
• ICH Guidelines (Q8, Q9, Q10, Q11)
• WHO Technical Report Series (TRS)
• National Ministry of Health (MOH) regulatory requirements

Supported markets include:

• Indonesia
• Philippines
• Vietnam
• Thailand
• Malaysia
• Sri Lanka
• Bangladesh
• Nepal
• Cambodia
• Myanmar
• Kazakhstan
• Uzbekistan

Industries We Serve

• Pharmaceutical Finished Dosage Manufacturers
• Contract Development & Manufacturing Organizations (CDMOs)
• Export-oriented pharmaceutical companies
• Regulatory affairs consultancies
• Brand owners and Marketing Authorization Holders (MAHs)

Why Choose ProdDev

✅ 600+ PDRs successfully prepared and reviewed
✅ Deep expertise in Asian pharmaceutical regulatory requirements
✅ Authority-ready, science-driven documentation
✅ Integrated regulatory, formulation, and QA expertise
✅ End-to-end lifecycle support
✅ Strict confidentiality and deadline-driven execution

Our Approach

1️⃣ Product Understanding & Scope Finalization

2️⃣ Regulatory and Development Requirement Mapping

3️⃣ PDR Protocol Preparation / Review

4️⃣ Scientific PDR Report Writing with Supporting Data

5️⃣ Independent QA & Regulatory Review

6️⃣ Submission-Ready Documentation Delivery

7️⃣ Post-submission Query Support

Who We Work With

We support pharmaceutical companies across Asian markets, including:

South Asia | Southeast Asia | Central Asia | East Asia

Our PDR documentation is designed to be regulatory-submission ready and inspection-acceptable for Asian drug authorities.

Confidentiality & Compliance

All projects are handled under strict:

• Confidentiality agreements (NDAs)
• Data integrity and documentation traceability principles
• GMP and regulatory compliance standards

Get in Touch

Looking for PDR Protocol or Product Development Report preparation, review, or regulatory query support for Asian markets?

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