Global Product Development Report (PDR) Services – Pharma

For Pharmaceutical Companies Supplying to Gambia

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 lifecycle support for pharmaceutical manufacturers and exporters supplying medicines to The Gambia.

Since 2008, we have prepared and reviewed 600+ Product Development Reports (PDRs) across Asia, Middle East, Africa, Europe, and LATAM, ensuring robust scientific justification, regulatory alignment, and authority acceptance.

Who We Are

ProdDev is a specialized pharmaceutical product development documentation partner, focused exclusively on PDR Protocol & Report preparation, independent review, and regulatory lifecycle support.

Our team includes:

• Pharmaceutical formulation scientists

• Regulatory affairs professionals

• QA & GMP experts

• Technical documentation specialists

We bridge:

• Formulation development → Scale-up → Regulatory submission

• R&D data → Authority-acceptable documentation

• Development stage → Commercial, tender & public health readiness

Our Core PDR Services – Gambia Focus

📘 Product Development Report (PDR) Documentation

• Complete PDR Protocol preparation

• PDR Report writing with strong scientific & regulatory justification

• Development rationale for QTPP, CQA, CMA & CPP

• Comparative formulation development & optimization studies

• Excipient selection and compatibility justification

• Scale-up strategy & manufacturing readiness

🔍 PDR Review & Gap Assessment

• Independent technical & regulatory review of existing PDRs

• Gap assessment against ICH, CTD & Gambia authority expectations

• Risk identification and corrective recommendations

• Authority-focused restructuring of PDR content

📊 Backup Data Compilation & Presentation

• Comprehensive development backup data

• Lab, pilot & exhibit batch data

• Dissolution development & comparative profiles

• Stability development data (where applicable)

• Process optimization & robustness studies

📨 Regulatory Query Handling (Post-Submission)

• Responses to Medicines Control Agency (MCA) 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)

Regulatory & Technical Alignment

Our PDRs for Gambia-bound products align with:

• ICH Guidelines (Q8, Q9, Q10, Q11)

• CTD / eCTD dossier structure

• WHO Technical Report Series (TRS)

• Gambia MCA / Ministry of Health requirements

• Export market expectations for West Africa, ECOWAS & ROW

Industries We Serve

• Pharmaceutical Finished Dosage Form manufacturers

• Export-oriented pharma companies

• Contract manufacturers & CDMOs

• Regulatory affairs & dossier consultancies

• Brand owners & Marketing Authorization Holders (MAHs)

Why Companies Supplying to The Gambia Choose ProdDev

✅ 600+ PDRs delivered globally
✅ Experience with West African & ECOWAS registrations
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & Regulatory expertise
✅ End-to-end lifecycle & query support
✅ Confidential, reliable & deadline-driven execution

Our Proven PDR Execution 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 & MCA query support

Who We Work With

We support companies supplying medicines to:
Gambia | West Africa | ECOWAS | Middle East | Asia | LATAM

From essential medicines and public tenders to imported branded generics, our PDRs are designed to be inspection-ready and authority-acceptable.

Confidentiality & Compliance

All projects are managed under strict:

• Confidentiality & non-disclosure agreements

• Data integrity (ALCOA+) principles

• GMP & global regulatory compliance standards