ProdDev – Global Product Development Report (PDR) Services for Romania
EU-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 and review services for pharmaceutical companies operating in Romania and supplying to Romania, the European Union, and global markets.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, and regulatory teams across Europe, Asia, Middle East, Africa, and LATAM, ensuring scientific depth, EU 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 for regulated and semi-regulated markets.
Our multidisciplinary team includes:
Pharmaceutical formulation scientists
EU regulatory affairs professionals
QA & GMP experts
Technical documentation specialists
We bridge the gap between:
Formulation development → Scale-up → EU regulatory submission
R&D data → EMA / national authority-acceptable documentation
Development stage → Commercial manufacturing readiness
Our Core PDR Services – Romania (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing aligned with EU expectations
Development rationale for QTPP, CQA, CMA & CPP
Comparative formulation development & optimization studies
Excipient selection & compatibility justification
Scale-up, validation readiness & manufacturing justification
🔍 PDR Review & Gap Assessment
Independent technical & EU regulatory review of existing PDRs
Gap assessment against ICH, CTD & EU GMP requirements
Risk identification with corrective & preventive actions
Authority-focused restructuring to improve approval success
📊 Backup Data Compilation & Presentation
Compilation of complete development backup data
Lab-scale, pilot-scale & exhibit batch summaries
Dissolution development & comparative profiles
Stability development data (ICH Q1 compliant)
Process optimization & robustness documentation
📨 Regulatory Query Handling (Post-Submission)
National Agency for Medicines and Medical Devices of Romania (ANMDMR) / EU authorities PDR-related query responses
Scientific justification for development-related deficiencies
Post-submission & post-inspection support
Lifecycle maintenance & updates of 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 for Romania & EU Markets
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
EU CTD / eCTD dossier structures
EMA, CMDh & national authority expectations
WHO Technical Report Series (TRS) (where applicable)
EU GMP & lifecycle variation requirements
Industries We Serve in Romania
Pharmaceutical finished dosage manufacturers
Importers & marketing authorization holders (MAHs)
Contract Development & Manufacturing Organizations (CDMOs)
Regulatory affairs & compliance consultancies
Export-oriented pharmaceutical companies
Why Romania-Based Clients Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with EU & regulated markets
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & EU Regulatory expertise
✅ End-to-end lifecycle & authority query support
✅ Strict confidentiality & data integrity compliance
Our Structured Approach
Product understanding & scope finalization
EU regulatory & development requirement mapping
PDR Protocol preparation / review
Scientific PDR Report writing with complete backup data
Independent QA & EU regulatory review
Submission-ready delivery & post-submission support
Who We Work With
We support Romania-based companies supplying to:
Domestic ANMDMR registrations | EU (DCP / MRP / Centralised) | UK | Middle East | Africa | LATAM
Our PDRs are designed to be inspection-ready, regulator-friendly, and submission-acceptable.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality agreements
Data integrity principles
EU GMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or EU regulatory query support for your pharmaceutical products in Romania?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.