ProdDev – Global Product Development Report (PDR) Services for the United States
FDA-Aligned | Authority-Ready | Globally Trusted
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 operating in the United States and supplying to domestic and global regulated markets.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for innovators, generic manufacturers, CDMOs, and regulatory teams worldwide—ensuring robust science, FDA alignment, and inspection-ready documentation.
Who We Are
ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol & Report preparation, review, and full lifecycle support.
Our multidisciplinary team includes:
Pharmaceutical formulation scientists
Regulatory affairs professionals (US FDA expertise)
QA & GMP experts
Technical documentation specialists
We bridge the gap between:
Formulation development → Scale-up → FDA submission
R&D data → FDA-acceptable documentation
Development stage → Commercial manufacturing readiness
Our Core PDR Services – United States (Pharma)
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
Scientific PDR Report writing with clear development rationale
Justification for QTPP, CQA, CMA & CPP (QbD-driven)
Comparative formulation development & optimization studies
Excipient selection & compatibility justification
Scale-up, control strategy & manufacturing readiness documentation
🔍 PDR Review & Gap Assessment
Independent technical & regulatory review of existing PDRs
Gap assessment against US FDA, ICH & CTD expectations
Risk identification with corrective & preventive recommendations
Authority-focused restructuring to strengthen FDA acceptability
📊 Backup Data Compilation & Presentation
Compilation of complete development backup data
Lab-scale, pilot-scale & exhibit/registration batch summaries
Dissolution method development & comparative profiles
Stability development data (ICH Q1A–Q1F aligned)
Process optimization, robustness & control strategy data
📨 Regulatory Query Handling (Post-Submission)
US FDA development-related query responses
Scientific justifications for CQA/QbD, dissolution, scale-up & stability
Post-submission & post-inspection support
Lifecycle maintenance & 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 the United States & Global Markets
Our PDRs are prepared in alignment with:
ICH Guidelines (Q8, Q9, Q10, Q11)
US FDA expectations for ANDA & NDA submissions
CTD / eCTD Module 3 requirements
FDA Guidance for Industry (QbD, dissolution, stability)
WHO Technical Report Series (TRS) (where applicable)
EU, UK, Canada, LATAM & ROW export frameworks
Industries We Serve in the United States
Generic & specialty pharmaceutical manufacturers
Innovator companies (pre-approval & lifecycle phases)
Contract Development & Manufacturing Organizations (CDMOs)
Regulatory affairs & compliance consultancies
Marketing Authorization Holders (MAHs)
Why US-Based Clients Choose ProdDev
✅ 600+ PDRs successfully prepared & reviewed
✅ Strong experience with US FDA-regulated submissions
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & Regulatory expertise
✅ End-to-end lifecycle & FDA query support
✅ Strict confidentiality & data integrity
Our Structured Approach
Product understanding & scope finalization
FDA & 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 US-based and global companies supplying to:
US FDA registrations | Canada | EU & UK | LATAM | Asia | ROW
Our PDRs are designed to be inspection-ready, FDA-friendly, and submission-acceptable.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality agreements
Data integrity principles (ALCOA+)
cGMP & international regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or US FDA regulatory query support for your pharmaceutical products?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.