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

Regulatory-Compliant | Authority-Ready | Africa 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 African regulatory markets.

Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, and regulatory teams supplying medicines across African countries, ensuring technical accuracy, regulatory compliance, and regulatory 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 regulatory 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 – Africa Pharma

📘 Product Development Report (PDR) Documentation

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

🔍 PDR Review & Gap Assessment

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

📊 Development Data Compilation & Presentation

Complete compilation of development stage backup data, including:

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

📨 Regulatory Query Support

Support for MOH and National Drug Authority queries related to product development

Services include:

• Scientific justification for development-related queries
• Regulatory deficiency response preparation
• Post-submission query 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 and semi-solid formulations
• Sterile and non-sterile dosage forms (documentation support)
• Fixed Dose Combinations (FDCs)

African Regulatory Alignment

Our PDR documentation aligns with major African regulatory frameworks and international standards, including:

• ICH Guidelines (Q8, Q9, Q10, Q11)
• CTD / eCTD submission format
• World Health Organization Technical Report Series (TRS)
• National Ministry of Health (MOH) requirements
• Regional harmonization initiatives such as African Medicines Agency (AMA) programs

African Markets We Support

Our PDR documentation supports pharmaceutical submissions in countries such as:

• Nigeria
• Kenya
• Ghana
• Ethiopia
• Tanzania
• Uganda
• South Africa
• Zambia
• Zimbabwe
• Botswana

Industries We Serve

• Pharmaceutical Finished Dosage Form manufacturers
• Contract Development & Manufacturing Organizations (CDMOs)
• Export-focused pharmaceutical companies
• Regulatory affairs consultancies
• Marketing Authorization Holders (MAHs)
• Pharmaceutical brand owners

Why Choose ProdDev

✅ 600+ PDRs prepared and reviewed successfully
✅ Extensive experience with African regulatory expectations
✅ Authority-ready scientific documentation
✅ Integrated regulatory, formulation, and QA expertise
✅ Complete lifecycle documentation support
✅ Confidential, reliable and deadline-driven services

Our Approach

1️⃣ Product Understanding & Scope Definition

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 Regulatory Query and Deficiency Support

Who We Work With

We support pharmaceutical companies supplying to African pharmaceutical markets, including:

West Africa | East Africa | Central Africa | Southern Africa

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

Confidentiality & Compliance

All projects are executed under strict:

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

Get in Touch

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

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