Global Product Development Report (PDR) Services – Pharma

For Pharmaceutical Companies in Colombia

Regulatory-Compliant | Authority-Ready | Globally Trusted

ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) Protocol & Report preparation, review, and regulatory support services for pharmaceutical manufacturers, importers, exporters, CDMOs, and marketing authorization holders in Colombia.

Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical companies across LATAM, North America, Europe, Asia, Middle East, and Africa, ensuring technical accuracy, regulatory compliance, and smooth acceptance by health authorities.

Why PDR Is Critical for Colombia Pharma Companies

For pharmaceutical companies operating in Colombia, a scientifically robust Product Development Report (PDR) is a key quality document supporting:

• INVIMA product registration and technical evaluation

• CTD / eCTD (Module 3 – Quality) dossier submissions

• New registrations, renewals & post-approval variations

• Local manufacturing, contract manufacturing & technology transfer

• Readiness for INVIMA GMP inspections, WHO & PIC/S-aligned reviews

ProdDev delivers science-driven, INVIMA-aligned, and globally acceptable PDR documentation.

Who We Are

ProdDev is a specialized pharmaceutical development documentation service provider, focused exclusively on:

• PDR Protocol preparation

• PDR Report writing & independent review

• Product development lifecycle & regulatory support

Our Multidisciplinary Team

• Pharmaceutical formulation scientists

• Regulatory affairs professionals

• QA & GMP experts

• Technical documentation specialists

We bridge the gap between:

• Formulation development → Scale-up → Regulatory approval

• R&D data → Authority-acceptable documentation

• Development stage → Commercial & export readiness

Our Core PDR Services – Pharma (Colombia Focused)

📘 Product Development Report (PDR) Documentation

• Complete PDR Protocol preparation

• PDR Report writing with strong scientific justification

• Development rationale for QTPP, CQA, CMA & CPP

• Comparative development studies & optimization data

• Excipient selection & compatibility justification

• Scale-up and manufacturing readiness justification

🔍 PDR Review & Gap Assessment

• Independent technical & regulatory review of existing PDRs

• Gap assessment against ICH, CTD & INVIMA expectations

• Risk identification with corrective recommendations

• Authority-focused restructuring of PDR content

📊 Backup Data Compilation & Presentation

• Compilation of complete development backup data

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

• Dissolution development & comparative profiles

• Stability development data (where applicable)

• Process optimization & robustness studies

📨 Regulatory Query Handling (Post-Submission)

• Responses to INVIMA development-related queries

• Scientific justification for quality & development 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)

Global Regulatory Alignment

Our PDR documents are prepared in accordance with:

• ICH Guidelines (Q8, Q9, Q10, Q11)

• CTD / eCTD dossier structure

• WHO Technical Report Series (TRS)

• INVIMA Colombia regulatory requirements

• US FDA, EU EMA, ASEAN, GCC & LATAM frameworks

This ensures Colombia-registered and export products meet regional and global regulatory expectations.

Industries We Serve in Colombia

• Pharmaceutical finished dosage manufacturers

• API & finished product importers/exporters

• Contract Development & Manufacturing Organizations (CDMOs)

• Marketing Authorization Holders (MAHs)

• Regulatory affairs & compliance consultancies

Why Colombia Pharma Companies Choose ProdDev

✅ 600+ PDRs successfully prepared & reviewed
✅ Strong INVIMA & LATAM regulatory experience
✅ Inspection-ready, authority-focused documentation
✅ Integrated R&D, QA & Regulatory expertise
✅ End-to-end product development lifecycle support
✅ Confidential, reliable & deadline-driven execution

Our Structured PDR 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 & authority query support

Who We Work With

We support pharmaceutical clients across:

Colombia | LATAM | North America | Europe | Middle East | Asia | Africa

From INVIMA submissions to global registrations, our PDRs are designed to be authority-ready and inspection-acceptable.

Confidentiality & Compliance

All projects are handled under strict:

• Confidentiality agreements

• Data integrity principles

• GMP & international regulatory compliance standards

Get in Touch – Colombia PDR Specialists

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

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