Kolkata
India-Compliant | Manufacturing & Export-Focused | Globally Aligned
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 based in Kolkata—an established eastern India pharma manufacturing, API, and export hub—supporting domestic and international 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, 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 – Kolkata (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 minimize 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 / West Bengal State FDA / US FDA / EU / MOH query responses
Scientific justification for formulation, QbD, scale-up & stability issues
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 Kolkata-Based Companies
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
CDSCO & West Bengal State FDA requirements
US FDA, EU, UK MHRA, WHO, PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
Industries We Serve in Kolkata
Pharmaceutical finished dosage manufacturers
API & bulk drug manufacturers
Export-oriented pharma companies
Contract Manufacturing Organizations (CMOs & CDMOs)
Marketing Authorization Holders (MAHs) & RA teams
Kolkata’s strong manufacturing + port-led export ecosystem requires scientifically sound, inspection-ready development documentation—this is where ProdDev consistently delivers value.
Why Kolkata-Based Companies Choose ProdDev
✅ 600+ PDRs successfully delivered
✅ Strong experience with eastern India pharma operations
✅ 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 & 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 & authority query support
Who We Work With
We support Kolkata-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 Kolkata for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd