ProdDev – Global Product Development Report (PDR) Services in Nashik
ndia-Compliant | Manufacturing-Focused | Globally Aligned
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 Nashik—a fast-growing pharma manufacturing and formulation hub in Maharashtra—supporting domestic and global regulatory submissions.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for Indian manufacturers, exporters, MAHs, and CDMOs, enabling approvals across India, US, EU, UK, ASEAN, GCC, Africa, CIS & LATAM.
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
Regulatory affairs professionals (India & global markets)
QA & GMP experts
Technical documentation specialists
We bridge the gap between:
Formulation & process development → Scale-up → Regulatory submission
R&D and manufacturing data → Authority-acceptable documentation
Development stage → Commercial manufacturing readiness
Our Core PDR Services – Nashik (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with robust, QbD-aligned rationale
Justification for QTPP, CQA, CMA & CPP
Comparative formulation development & optimization 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, CDSCO & export-market expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to reduce regulatory observations
📊 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 (ICH Q1 aligned)
Process optimization, robustness & control strategy documentation
📨 Regulatory Query Handling (Post-Submission)
CDSCO / Maharashtra State FDA / US FDA / EU / MOH query responses
Scientific justification for formulation, QbD, scale-up & stability observations
Post-submission & post-approval lifecycle support
PDR updates for variations & renewals
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 Nashik-Based Companies
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
CDSCO & Maharashtra State FDA requirements
US FDA, EU, UK MHRA, WHO, PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
Industries We Serve in Nashik
Pharmaceutical finished dosage manufacturers
Small, mid-size & large formulation plants
Export-oriented pharma companies
Contract Manufacturing Organizations (CMOs & CDMOs)
Marketing Authorization Holders (MAHs)
Nashik’s expanding manufacturing and export ecosystem requires robust, inspection-ready development documentation—this is where ProdDev consistently adds value.
Why Nashik-Based Companies Choose ProdDev
✅ 600+ PDRs successfully delivered
✅ Strong experience with Maharashtra pharma operations
✅ 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 understanding & development scope finalization
India & global regulatory requirement mapping
PDR Protocol preparation / 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 Nashik-based companies supplying to:
India (CDSCO & State FDA) | US | EU | UK | ASEAN | GCC | Africa | LATAM
Our PDRs are designed to be inspection-ready, regulator-friendly, and submission-acceptable.
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 in Nashik for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.