ProdDev – Global Product Development Report (PDR) Services in Ahmedabad
India-Compliant | Global Regulatory Aligned | Authority-Ready
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 Ahmedabad and supplying to India, regulated, and semi-regulated global markets.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical manufacturers, exporters, and regulatory teams—supporting 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, technical review, and lifecycle support.
Our expert team includes:
Pharmaceutical formulation scientists
Regulatory affairs professionals (India & global markets)
QA & GMP experts
Technical documentation specialists
We bridge the gap between:
Formulation development → Scale-up → Regulatory submission
R&D data → Authority-acceptable documentation
Development stage → Commercial manufacturing readiness
Our Core PDR Services – Ahmedabad (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with strong development rationale
Justification for QTPP, CQA, CMA & CPP (QbD aligned)
Comparative formulation development & optimization studies
Excipient selection & compatibility justification
Scale-up & commercial manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against ICH, CTD, CDSCO & global authority expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring for faster approvals
📊 Backup Data Compilation & Presentation
Complete development backup data compilation
Lab-scale, pilot-scale & exhibit batch summaries
Dissolution development & comparative profiles
Stability development data (ICH Q1 aligned)
Process optimization & robustness documentation
📨 Regulatory Query Handling (Post-Submission)
CDSCO / State FDA / Global MOH / FDA query responses
Scientific justification for development-related deficiencies
Post-submission & post-inspection support
Lifecycle 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 Ahmedabad-Based Companies
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
CDSCO & State FDA (India) requirements
US FDA, EU, UK MHRA, WHO, PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
Industries We Serve in Ahmedabad
Pharmaceutical finished dosage manufacturers
API & formulation manufacturers
Export-oriented pharma companies
Contract Manufacturing Organizations (CMOs & CDMOs)
Regulatory affairs & compliance consultancies
Ahmedabad is a key pharma manufacturing and export hub, and our PDRs are tailored to meet both Indian GMP realities and global regulatory expectations.
Why Ahmedabad-Based Companies Choose ProdDev
✅ 600+ PDRs successfully delivered
✅ Strong experience with Gujarat pharma ecosystem
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & Regulatory expertise
✅ End-to-end lifecycle & inspection support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product understanding & 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 & authority query support
Who We Work With
We support Ahmedabad-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 Ahmedabad for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.