ProdDev – Global Product Development Report (PDR) Services for the United Kingdom
MHRA-Aligned | UK & EU 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 the United Kingdom—a leading global hub for pharmaceutical manufacturing, life sciences innovation, and international supply—supporting UK national and global 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 full lifecycle regulatory support.
Our multidisciplinary team includes:
Pharmaceutical formulation & development scientists
UK, 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, QA & manufacturing data → Authority-acceptable documentation
Development stage → UK & global commercial readiness
Our Core PDR Services – United Kingdom (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 & MHRA expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to reduce 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 Zone II
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
MHRA / 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 the United Kingdom
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
MHRA (UK) quality & CMC requirements
PIC/S & WHO TRS principles
Export-market requirements (EU, US, GCC, Africa & LATAM)
We ensure documentation meets UK regulatory expectations while remaining globally acceptable.
Industries We Serve in the United Kingdom
Pharmaceutical finished dosage manufacturers
API & intermediate producers
Innovator, generic & specialty pharma companies
Contract Development & Manufacturing Organizations (CDMOs)
UK & global Marketing Authorization Holders (MAHs)
The UK’s role as a regulatory reference market and global exporter demands inspection-ready, authority-focused development documentation—this is where ProdDev consistently delivers value.
Why UK-Based Companies Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with MHRA & international authority expectations
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & regulatory expertise
✅ End-to-end lifecycle & authority query support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product & UK / target-market understanding
UK & 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 UK-based companies supplying to:
United Kingdom | EU | 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+)
UK GMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your UK-manufactured pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.