Global Product Development Report (PDR) Services – Pharma

ProdDev - Global Product Development Report (PDR) Services – Pharma

Regulatory-Compliant | Authority-Ready | Globally Trusted

ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) document writing and review services for pharmaceutical products across regulated and semi-regulated global markets.

Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, and regulatory teams across Asia, Middle East, Africa, Europe, and LATAM, 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 & Report preparation, review, and lifecycle support.

Our team comprises:

• 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 data → Regulatory-acceptable documentation

• Development stage → Commercial readiness

Our Core PDR Services – Pharma

📘 Product Development Report (PDR) Documentation

• Complete PDR Protocol preparation

• PDR Report writing with scientific justification

• Development rationale for QTPP, CQA, CMA & CPP

• Comparative development studies and optimization data

• 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 & country-specific guidelines

• Risk identification and corrective recommendations

• Authority-focused restructuring of PDR content

📊 Backup Data Compilation & Presentation

• Inclusion of all development backup data

• Lab-scale, pilot-scale, and exhibit batch data

• Dissolution development & comparative profiles

• Stability development data (as applicable)

• Process optimization and robustness data

📨 Regulatory Query Handling (Post-Operations)

• MOH / FDA / Health Authority query responses related to PDR

• Scientific justification for development-related deficiencies

• Post-submission and 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)

Global Regulatory Alignment

Our PDR documents are prepared in line with:

• ICH Guidelines (Q8, Q9, Q10, Q11)

• CTD / eCTD expectations

• WHO Technical Report Series (TRS)

• Country-specific MOH / FDA requirements

• EU, ASEAN, GCC, LATAM & ROW regulatory frameworks

Industries We Serve

• Pharmaceutical Finished Dosage Manufacturers

• Contract Development & Manufacturing Organizations (CDMOs)

• Export-oriented pharma companies

• Regulatory affairs consultancies

• Brand owners & marketing authorization holders

Why Choose ProdDev

✅ 600+ PDRs successfully prepared & reviewed
✅ Global experience across 5 continents
✅ Authority-ready, science-driven documentation
✅ Strong regulatory & QA integration
✅ End-to-end lifecycle support
✅ Confidential, reliable & deadline-driven execution

Our 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 & Query Support

Who We Work With

We support clients located in:
Asia | Middle East | Africa | Europe | LATAM

From emerging markets to regulated territories, our PDRs are designed to be inspection-ready and submission-acceptable.

Confidentiality & Compliance

All projects are handled under strict:

• Confidentiality agreements

• Data integrity principles

• GMP & regulatory compliance standards

Get in Touch

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

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

“600+ PDRs Delivered Across Global Markets.”

Excellence in PDR Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Global Product Development Report (PDR) Services – Pharma

1. What is a Product Development Report (PDR) in pharmaceuticals?

A Product Development Report (PDR) is a scientific and regulatory document that describes the complete formulation and process development of a pharmaceutical product. It includes development rationale, optimization studies, excipient selection, process parameters, and supporting data required for regulatory submissions.

2. Which regulatory guidelines are followed for PDR preparation?

Our PDRs are prepared in accordance with ICH Q8, Q9, Q10, and Q11 guidelines, CTD / eCTD expectations, WHO TRS, and country-specific MOH / FDA requirements applicable to the target market.

3. Do you prepare both PDR Protocols and PDR Reports?

Yes. ProdDev provides end-to-end PDR services, including:

• PDR Protocol preparation

• PDR Report writing

• Review and gap assessment of existing PDRs

• Lifecycle updates and post-submission support

4. Can you review and improve an existing Product Development Report?

Yes. We offer independent technical and regulatory review of existing PDRs, including gap assessment, restructuring, and strengthening of scientific justifications to ensure regulatory acceptability.

5. Do you include all development backup data in the PDR?

Yes. Our PDRs include complete backup data, such as:

• Lab-scale and pilot-scale development data

• Dissolution development and comparative profiles

• Excipient compatibility and optimization data

• Process development and robustness data

• Stability development data (where applicable)

6. Which dosage forms are covered under your PDR services?

We support a wide range of dosage forms, including:

• Immediate-release, modified-release, and delayed-release tablets

• Hard gelatin and HPMC capsules

• Oral liquids and suspensions

• Powders and granules

• Topical and semi-solid products

• Fixed Dose Combinations (FDCs)

7. Do you support sterile product PDR documentation?

Yes. We provide documentation support for sterile products, including development rationale, process design, and regulatory alignment. (Note: Services are limited to documentation and scientific justification.)

8. Can you handle regulatory authority queries related to PDR after submission?

Yes. ProdDev provides post-submission and post-approval query handling, including MOH / FDA deficiency responses related to formulation and product development.

9. Which markets do you support for PDR services?

We support pharmaceutical companies targeting Asia, Middle East, Africa, Europe, and LATAM, including both regulated and semi-regulated markets.

10. How long does it take to prepare a Product Development Report?

Timelines depend on product complexity, dosage form, and availability of development data. Typically:

• PDR Protocol: 3–5 working days

• Complete PDR Report: 10–20 working days

11. Can you prepare PDRs for generic as well as new products?

Yes. We prepare PDRs for:

• Generic pharmaceutical products

• Line extensions

• Fixed Dose Combinations (FDCs)

• Reformulated and scale-up products

12. Will the PDR be ready for CTD / eCTD submission?

Yes. Our PDRs are written in a CTD-aligned, authority-ready format, suitable for inclusion in Module 3 (Pharmaceutical Development).

13. Do you sign confidentiality agreements (NDAs)?

Yes. All projects are handled under strict confidentiality agreements to protect client data, intellectual property, and proprietary development information.

14. Why should we choose ProdDev for PDR services?

ProdDev offers:

• 600+ PDRs successfully delivered

• Global regulatory experience

• Science-driven and compliance-focused documentation

• Strong post-submission query support

• Dedicated pharmaceutical development experts

15. How can we start a PDR project with ProdDev?

You can start by sharing:

• Product details and target markets

• Available development data

• Submission timelines

Our team will evaluate the scope and provide a customized proposal and timeline.