Global Product Development Report (PDR) Services – Pharma
egulatory-Compliant | Authority-Ready | Globally Trusted
ProdDev – A Scientific Arm of Zoesoe Exports Pvt. Ltd.
PDR Services for Pharmaceutical Companies in New Zealand and Beyond
Since 2008, ProdDev has been delivering high-quality Product Development Report (PDR) services to pharmaceutical manufacturers worldwide, including New Zealand. We specialize in preparing, reviewing, and supporting PDR documentation for pharmaceutical products across regulated and semi-regulated markets. With over 600 successful PDRs delivered, we ensure that your product development reports meet the highest standards of regulatory compliance, scientific integrity, and authority acceptance.
Who We Are
ProdDev is a specialized service provider focused exclusively on creating, reviewing, and supporting PDR documentation. Our team consists of experts in pharmaceutical formulation, regulatory affairs, QA, GMP, and technical documentation, helping bridge the gap between formulation development and regulatory submission.
We provide services for pharmaceutical companies in New Zealand, ensuring that your product development reports are ready for regulatory review and submission in local and global markets.
Our Core PDR Services – Pharma
📘 Product Development Report (PDR) Documentation
PDR Protocol preparation for development projects
PDR Report writing with scientific justification and data
Development rationale for QTPP (Quality Target Product Profile), CQA (Critical Quality Attributes), CMA (Critical Material Attributes), and CPP (Critical Process Parameters)
Comparative development studies and optimization data
Excipient selection & compatibility justification
Scale-up & manufacturing readiness justification
🔍 PDR Review & Gap Assessment
Independent technical and regulatory review of existing PDRs
Gap analysis based on ICH, CTD, and New Zealand-specific guidelines (including MedSafe, the New Zealand Medicines and Medical Devices Safety Authority)
Risk identification and corrective actions
Restructuring PDR content for authority acceptance
📊 Backup Data Compilation & Presentation
Inclusion of all necessary development backup data
Lab-scale, pilot-scale, and exhibit batch data
Dissolution development and comparative dissolution profiles
Stability development data (as applicable)
Process optimization and robustness data
📨 Regulatory Query Handling (Post-Operations)
Responses to MOH / FDA / MedSafe regulatory queries related to PDR
Providing scientific justification for development-related deficiencies
Post-submission and post-inspection support
Lifecycle updates to PDR documentation as necessary
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)
Global Regulatory Alignment
Our PDR documents are prepared in alignment with global and New Zealand-specific regulatory frameworks:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD expectations
WHO Technical Report Series (TRS)
New Zealand MOH / MedSafe regulatory guidelines
EU, ASEAN, GCC, LATAM, and ROW regulatory frameworks
Industries We Serve
We cater to a diverse range of industries within the pharmaceutical sector:
Pharmaceutical Finished Dosage Manufacturers
Contract Development & Manufacturing Organizations (CDMOs)
Export-oriented pharmaceutical companies
Regulatory affairs consultancies
Brand owners & marketing authorization holders
Why Choose ProdDev?
Over 600 PDRs successfully prepared and reviewed
Extensive global experience, with a strong presence in New Zealand
Authority-ready, scientifically driven documentation
Deep understanding of regulatory affairs and QA integration
End-to-end lifecycle support
Confidential, reliable, and deadline-driven execution
Our Approach
Product Understanding & Scope Finalization
Regulatory & Development Requirement Mapping
PDR Protocol Preparation / Review
Scientific PDR Report Writing with all required backup data
Independent QA & Regulatory Review
Submission-Ready Delivery and Query Support
Serving New Zealand’s Pharmaceutical Industry
We are proud to support pharmaceutical companies in New Zealand, ensuring that their PDRs meet both local and international regulatory standards. Whether you're based in Auckland, Wellington, Christchurch, or any other part of New Zealand, our services are tailored to help your company navigate the regulatory landscape and get products to market.
Our expertise in MedSafe (New Zealand’s Medicines and Medical Devices Safety Authority) and the Medicines Act 1981 ensures that all product development reports are aligned with local requirements and ready for smooth regulatory review and submission.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality agreements
Data integrity principles
GMP and regulatory compliance standards
Contact Us
Looking for PDR Protocol & Report preparation, review, or regulatory query support for your pharmaceutical product in New Zealand?
📩 Contact ProdDev – Your Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.
Let us assist you in preparing, reviewing, and submitting your Product Development Reports (PDRs) with confidence.