Global Product Development Report (PDR) Services – Pharma
DDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of Nepal’s Department of Drug Administration (DDA).
All studies strictly follow GCP, GLP, WHO TRS, ICH, and Nepal’s drug registration guidelines, ensuring compliance for both local regulatory submissions and international approvals.
💊 Core Services for Nepal (DDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by the DDA.
• Volunteer Selection: Healthy volunteers or relevant patient groups depending on therapeutic class.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee in Nepal.
• Protocol Development: BA/BE protocols aligned with DDA guidelines, ICH E6 (R2) GCP, and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug applications and post-approval variations under DDA standards.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Analysis: Calculation of f2 similarity factor for comparing test and reference profiles.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed in line with WHO TRS, ICH Q6A, and DDA-recognized scientific criteria.
• IVIVC Modeling: Level A, B, and C models to support prediction of in vivo performance.
• PK Predictive Modeling: Dissolution–PK modeling for regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV technologies for accurate drug quantification.
• Validation: Conducted per ICH M10, WHO TRS, and Nepal DDA requirements.
• Stability Methods: Stability-indicating methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Evaluation: Non-compartmental analysis (NCA).
• BE Statistical Assessment: Performed using internationally harmonized ICH/WHO methodologies accepted by DDA.
• Study Powering: Sample-size and power calculations for conclusive BE demonstration.
📑 DDA-Ready Regulatory Documentation
We prepare complete pharmaceutical registration documents for submission to the Department of Drug Administration (DDA) Nepal, including:
• Clinical Study Protocol (Nepal-compliant)
• Informed Consent Forms (ICF) per Nepalese research ethics
• Investigator Brochure
• Clinical Study Report (CSR) prepared as per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted to DDA requirements
✨ Why Choose BioEquiGlobal for the Nepalese Market?
• Regulatory Alignment: BA/BE study designs, dissolution testing, and documentation tailored to Nepal’s DDA guidelines.
• Quality & Compliance: Operations aligned with GCP, GLP, and WHO TRS with internal QA oversight.
• Advanced Infrastructure: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Capabilities: Dossier preparation for Nepal DDA as well as US FDA, EMA, MHRA, GCC, TGA, ASEAN, and African regulatory agencies.
🗺️ BA/BE Study Workflow for Nepal
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution methods, and biowaiver feasibility.
Protocol Development: Drafting of Nepal DDA–compliant BA/BE protocols and supporting IRB approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored volunteer recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC review, and statistical BE assessment.
Documentation & Submission: Preparation of DDA-ready CSR, dissolution reports, validation data, and CTD/ACTD dossier modules.
Who We Support
• Nepalese pharmaceutical companies seeking DDA product registration
• CROs requiring BA/BE study outsourcing or bioanalytical support
• Regulatory teams needing Nepal DDA–compliant CTD/ACTD dossiersFor Pharmaceutical Companies Supplying to Nepal
Regulatory-Compliant | Authority-Ready | Globally Trusted
ProdDev, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Product Development Report (PDR) Protocol & Report preparation, review, and lifecycle support for pharmaceutical manufacturers and exporters supplying medicinal products to Nepal.
Since 2008, we have successfully prepared and reviewed 600+ Product Development Reports (PDRs) for pharmaceutical companies across Asia, Middle East, Africa, Europe, and LATAM, ensuring scientific soundness, regulatory compliance, and smooth authority acceptance.
Who We Are
ProdDev is a specialized pharmaceutical product development documentation service provider, focused exclusively on PDR Protocol & Report preparation, review, and regulatory lifecycle support.
Our multidisciplinary team includes:
Pharmaceutical formulation scientists
Regulatory affairs professionals
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 & import readiness
Our Core PDR Services – Nepal Focus
📘 Product Development Report (PDR) Documentation
Complete PDR Protocol preparation
PDR Report writing with strong scientific justification
Development rationale for QTPP, CQA, CMA & CPP
Comparative formulation development & optimization studies
Excipient selection and compatibility justification
Scale-up strategy & manufacturing readiness justification
🔍 PDR Review & Gap Assessment
Independent technical and regulatory review of existing PDRs
Gap assessment against ICH, CTD & Nepal DDA expectations
Identification of scientific, data & compliance gaps
Authority-focused restructuring of PDR content
📊 Backup Data Compilation & Presentation
Compilation of complete development backup data
Lab-scale, pilot-scale & exhibit batch data
Dissolution development & comparative profiles
Stability development data (where applicable)
Process optimization & robustness studies
📨 Regulatory Query Handling (Post-Submission)
Responses to Department of Drug Administration (DDA), Nepal queries
Scientific justification for development-related deficiencies
Post-submission & post-approval support
Lifecycle updates to 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 & Technical Alignment
Our PDRs for Nepal-bound products are prepared in line with:
ICH Guidelines (Q8, Q9, Q10, Q11)
CTD / eCTD dossier expectations
WHO Technical Report Series (TRS)
Nepal DDA registration requirements
Export market expectations for South Asia, ASEAN & ROW
Industries We Serve
Pharmaceutical Finished Dosage Form manufacturers
Export-oriented pharma companies
Contract manufacturers & CDMOs
Regulatory affairs & dossier consultancies
Brand owners & Marketing Authorization Holders (MAHs)
Why Companies Supplying to Nepal Choose ProdDev
✅ 600+ PDRs prepared & reviewed globally
✅ Strong experience with South Asian & emerging market registrations
✅ Authority-ready, science-driven documentation
✅ Integrated R&D, QA & Regulatory Affairs expertise
✅ End-to-end lifecycle & post-approval support
✅ Confidential, reliable & deadline-driven execution
Our Proven PDR Execution Approach
Product understanding & scope finalization
Regulatory & development 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 companies supplying medicines to:
Nepal | South Asia | ASEAN | Middle East | Africa | LATAM
From essential medicines to imported branded generics, our PDRs are designed to be inspection-ready and authority-acceptable.
Confidentiality & Compliance
All projects are handled under strict:
Confidentiality & non-disclosure agreements
Data integrity & ALCOA+ principles
GMP & global regulatory compliance standards
Get in Touch
Looking for PDR Protocol & Report preparation, review, or regulatory query support for pharmaceutical products supplied to Nepal?
📩 Contact ProdDev – Product Development Experts
A Scientific Arm of Zoesoe Exports Pvt. Ltd.
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