ProdDev – Global Product Development Report (PDR) Services in Ankleshwar
India-Compliant | Export-Focused | Authority-Ready
ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., offers end-to-end Product Development Report (PDR) Protocol & Report preparation and review services for pharmaceutical companies based in Ankleshwar—one of India’s most prominent API and formulation manufacturing hubs—supporting domestic and global regulatory submissions.
Since 2008, we have successfully prepared and reviewed 600+ PDRs for Indian manufacturers and exporters, 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 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 – Ankleshwar (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 & export-market expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to reduce regulatory observations
📊 Backup Data Compilation & Presentation
Complete development backup data compilation
Lab-scale, pilot-scale & exhibit/registration batch summaries
Dissolution development & comparative profiles
Stability development data (ICH Q1 aligned)
Process optimization & robustness documentation
📨 Regulatory Query Handling (Post-Submission)
CDSCO / State FDA / US FDA / EU / MOH development-related query responses
Scientific justification for formulation, scale-up & stability 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 Ankleshwar-Based Companies
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
CDSCO & Gujarat State FDA requirements
US FDA, EU, UK MHRA, WHO, PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
Industries We Serve in Ankleshwar
API & formulation manufacturers
Export-oriented pharmaceutical companies
Contract Manufacturing Organizations (CMOs & CDMOs)
R&D-driven midsize & large pharma units
Regulatory affairs & compliance consultancies
Ankleshwar’s strong chemical, API, and pharma manufacturing ecosystem demands robust, regulator-ready development documentation—this is where ProdDev adds measurable value.
Why Ankleshwar-Based Companies Choose ProdDev
✅ 600+ PDRs successfully delivered
✅ Deep understanding of GIDC Ankleshwar 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 & scope finalization
India & export-market 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 Ankleshwar-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 Ankleshwar for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.