ProdDev – Global Product Development Report (PDR) Services for Israel
MoH-Aligned | Export-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 Israel—a globally recognized pharmaceutical, biotech, and innovation-driven manufacturing hub—supporting Israel MoH registrations 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 and semi-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 full lifecycle regulatory support.
Our multidisciplinary team includes:
Pharmaceutical formulation & development scientists
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 → Commercial & export readiness
Our Core PDR Services – Israel (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with robust, QbD-aligned justification
Development rationale for QTPP, CQA, CMA & CPP
Comparative formulation & process development studies
Excipient selection & compatibility justification
Scale-up, tech transfer & manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD & Israel MoH 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 development & comparative profiles
Stability development data aligned with ICH climatic conditions
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
Israel Ministry of Health (MoH) / US FDA / EMA / WHO PDR-related query responses
Scientific justification for formulation, QbD, scale-up & stability observations
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 Israel
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
Israel Ministry of Health (MoH / AMAR) quality requirements
PIC/S & WHO TRS principles
Export-market requirements (US, EU, UK, GCC, Africa & LATAM)
We ensure documentation meets local MoH expectations while remaining globally acceptable.
Industries We Serve in Israel
Pharmaceutical finished dosage manufacturers
API & intermediate producers
Innovator, generic & specialty pharma companies
Contract Development & Manufacturing Organizations (CDMOs)
Marketing Authorization Holders (MAHs)
Israel’s strong focus on innovation, quality, and global exports requires inspection-ready, authority-focused development documentation—this is where ProdDev consistently delivers value.
Why Israel-Based Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with MoH, EMA & US FDA-aligned dossiers
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & international regulatory expertise
✅ End-to-end lifecycle & authority query support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product & target-market understanding
Israel MoH & 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 Israel-based companies supplying to:
Israel | US | EU | UK | 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+)
GMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your Israel-manufactured pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.