ProdDev – Product Development Report (PDR) Services for Bangladesh (Pharma)

Bangladesh Regulatory-Compliant | Authority-Ready | Globally Trusted

ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) protocol writing, report preparation, and review services for pharmaceutical manufacturers and exporters in Bangladesh.

Since 2008, we have successfully prepared and reviewed 600+ PDRs for pharmaceutical companies supplying to DGDA Bangladesh, as well as regulated and semi-regulated global markets including US, EU, UK, ASEAN, GCC, Africa, LATAM, and ROW.

Our PDRs are science-driven, regulator-focused, and submission-ready, supporting smooth approvals, reduced observations, and faster market entry.

Who We Are

ProdDev is a specialized pharmaceutical documentation service provider, focused exclusively on Product Development Report (PDR) Protocol & 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 critical gap between:

• Formulation development → Scale-up → DGDA / Global submissions
• R&D data → Regulatory-acceptable documentation
• Development stage → Commercial manufacturing readiness

Why PDR Is Critical for Bangladesh Pharma Companies

For pharmaceutical companies in Bangladesh, PDRs are essential for:

• DGDA product registration & renewals
• Export dossiers (CTD / eCTD)
• Technology transfer & scale-up justification
• Regulatory inspections & deficiency responses
• Post-approval variations & lifecycle management

Regulators expect clear scientific rationale, development logic, and data-backed decisions, not just compilation. ProdDev ensures your PDR meets these expectations.

Our Core PDR Services – Bangladesh Focus

📘 Product Development Report (PDR) Documentation

We prepare complete, authority-ready PDRs, including:

• PDR Protocol preparation
• Full PDR Report writing with scientific justification
• Development rationale for QTPP, CQA, CMA & CPP
• Formulation optimization & comparative development studies
• Excipient selection & compatibility justification
• Scale-up strategy & manufacturing readiness justification

Aligned with DGDA Bangladesh, WHO, and global CTD expectations.

🔍 PDR Review & Gap Assessment

Already have a PDR?

We provide independent technical and regulatory review, covering:

• Gap assessment against ICH, WHO TRS, CTD & DGDA guidelines
• Identification of scientific and regulatory weaknesses
• Risk assessment and corrective recommendations
• Authority-focused restructuring of PDR content
• Readiness check for export markets

📊 Backup Data Compilation & Presentation

We compile and structure complete development backup data, including:

• Lab-scale, pilot-scale & exhibit batch data
• Dissolution method development & comparative profiles
• Stability development data (as applicable)
• Process optimization & robustness studies
• Supporting tables, summaries & regulatory-friendly narratives

📨 Regulatory Query Handling (Post-Submission)

We support Bangladesh pharma companies during:

• DGDA deficiency responses related to PDR
• MOH / FDA / authority development-related queries
• Scientific justification for formulation or process changes
• Post-submission & post-inspection 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)

Regulatory Alignment (Bangladesh & Global)

Our PDRs are prepared in accordance with:

• ICH Guidelines (Q8, Q9, Q10, Q11)
• CTD / eCTD structure
• WHO Technical Report Series (TRS)
• DGDA Bangladesh requirements
• EU, ASEAN, GCC, Africa, LATAM & ROW regulations

Ensuring one PDR supports multiple markets wherever possible.

Industries We Serve in Bangladesh

• Pharmaceutical Finished Dosage Form manufacturers
• Export-oriented pharma companies
• Contract Development & Manufacturing Organizations (CDMOs)
• Regulatory affairs & compliance teams
• Brand owners & Marketing Authorization Holders

Why Choose ProdDev (Bangladesh Advantage)

✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with DGDA & export markets
✅ Science-driven, authority-acceptable documentation
✅ Integrated regulatory, QA & development approach
✅ End-to-end lifecycle support
✅ Strict confidentiality & deadline-driven execution

Our Structured Approach

1️⃣ Product understanding & scope finalization
2️⃣ Regulatory & development requirement mapping
3️⃣ PDR Protocol preparation / review
4️⃣ Scientific PDR report writing with backup data
5️⃣ Independent QA & regulatory review
6️⃣ Submission-ready delivery & query support

Who We Work With

We actively support pharmaceutical companies in:

Bangladesh | Asia | Middle East | Africa | Europe | LATAM

From local DGDA submissions to highly regulated global markets, our PDRs are built to withstand audits, inspections, and authority scrutiny.

Confidentiality & Compliance

All projects are handled under strict:

• Confidentiality agreements
• Data integrity principles
• GMP & regulatory compliance standards

Get in Touch – Bangladesh Pharma PDR Experts

Looking for PDR Protocol preparation, PDR Report writing, review, or regulatory query support for your pharmaceutical product in Bangladesh?

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