ProdDev – Global Product Development Report (PDR) Services in Gurgaon
ndia-Compliant | RA-Centric | 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 Gurgaon (Gurugram)—India’s leading pharma corporate, regulatory affairs, and MAH hub within Delhi NCR—supporting India and global regulatory submissions.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for Indian and international manufacturers, Marketing Authorization Holders (MAHs), CDMOs, and regulatory teams, 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 & development data → Regulatory-ready documentation
R&D, CMC & QA inputs → Authority-acceptable PDRs
Development stage → Commercial manufacturing readiness
Our Core PDR Services – Gurgaon (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with strong, QbD-driven 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 & global authority expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to reduce regulatory queries
📊 Backup Data Compilation & Presentation
Complete 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 / Haryana 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 Gurgaon-Based Companies
Our PDRs are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD Module 3 expectations
CDSCO & Haryana State FDA requirements
US FDA, EU, UK MHRA, WHO, PIC/S
ASEAN, GCC, Africa & LATAM regulatory frameworks
Industries We Serve in Gurgaon
Marketing Authorization Holders (MAHs)
Pharmaceutical corporate & regulatory affairs teams
Export-oriented pharma companies
Contract Development & Manufacturing Organizations (CDMOs)
Regulatory affairs & compliance consultancies
Gurgaon’s concentration of corporate HQs and global RA teams demands precise, authority-focused development documentation—this is where ProdDev consistently adds value.
Why Gurgaon-Based Companies Choose ProdDev
✅ 600+ PDRs successfully delivered
✅ Strong experience supporting MAHs & RA-led organizations
✅ 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 & 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 Gurgaon-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 Gurgaon (Gurugram) for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.