🇳🇵 Bioavailability & Bioequivalence (BA/BE) Studies Services for Nepal
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 dossiers