ProdDev – Global Product Development Report (PDR) Services for Ireland
EU-Aligned | EMA-Ready | Globally Trusted
ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) Protocol & Report preparation and review services for pharmaceutical companies based in Ireland—one of the world’s most important pharmaceutical manufacturing, biologics, and export hubs—supporting EU and international regulatory submissions.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, MAHs, CDMOs, and regulatory teams worldwide, ensuring scientific rigor, regulatory compliance, and authority acceptance across regulated markets.
Who We Are
ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol & Report preparation, independent technical review, and lifecycle regulatory support.
Our multidisciplinary team includes:
Pharmaceutical formulation & development scientists
EU & international regulatory affairs professionals
QA & GMP compliance experts
Technical documentation specialists
We bridge the gap between:
Formulation & CMC development → Scale-up → Regulatory submission
R&D, manufacturing & QA data → Authority-acceptable documentation
Development stage → EU & global commercial readiness
Our Core PDR Services – Ireland (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with strong, QbD-aligned rationale
Justification for QTPP, CQA, CMA & CPP
Comparative formulation development & optimization studies
Excipient selection & compatibility justification
Scale-up, tech transfer & commercial manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD & EU/EMA expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to minimize regulatory deficiencies
📊 Backup Data Compilation & Presentation
Comprehensive development backup data compilation
Lab-scale, pilot-scale & exhibit/registration batch summaries
Dissolution method development & comparative profiles
Stability development data aligned with ICH climatic Zone II
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
EMA / Health Products Regulatory Authority (HPRA) / EU Authorities / US FDA / WHO PDR-related query responses
Scientific justification for formulation, QbD, scale-up & stability issues
Post-submission & post-approval lifecycle support
PDR updates for variations, renewals & site changes
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 for Ireland
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
EMA & HPRA requirements
PIC/S & WHO TRS principles
Export-market requirements (UK, US, GCC, Africa & LATAM)
We ensure documentation meets Ireland’s stringent EU regulatory standards while remaining globally acceptable.
Industries We Serve in Ireland
Pharmaceutical & biotech manufacturers
Innovator, biologics & complex generics companies
Export-oriented pharma organizations
Contract Development & Manufacturing Organizations (CDMOs)
EU Marketing Authorization Holders (MAHs)
Ireland’s role as a global pharma manufacturing and export powerhouse demands inspection-ready, authority-focused development documentation—this is where ProdDev consistently delivers value.
Why Ireland-Based Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with EMA & HPRA authority expectations
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & EU regulatory expertise
✅ End-to-end lifecycle & authority query support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product & EU target-market understanding
EU & global regulatory requirement mapping
PDR Protocol preparation / critical review
Scientific PDR Report writing with complete backup data
Independent QA & regulatory review
Submission-ready delivery & post-submission support
Who We Work With
We support Ireland-based companies supplying to:
EU | UK | US | GCC | Africa | LATAM
Our PDRs are designed to be inspection-ready, regulator-friendly, and submission-acceptable across global markets.
Confidentiality & Compliance
All projects are executed under strict:
Confidentiality agreements
Data integrity principles (ALCOA+)
EU GMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your Ireland-manufactured pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.