🇲🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mongolia
Mongolia MOH/DMME–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of Mongolia’s Ministry of Health (MOH) and the Department of Medicines and Medical Equipment (DMME).
All studies comply with ICH, WHO TRS, GLP, GCP, and Mongolia’s Medicines Registration Guidelines, ensuring suitability for local drug registration and international submissions.
💊 Core Services for Mongolia (MOH/DMME) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover and parallel designs accepted by the DMME.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic class and risk profile.
• Ethics Approval: Approval from a registered Institutional Review Board (IRB)/Ethics Committee under Mongolian clinical research regulations.
• Protocol Development: Protocols aligned with ICH E6 (R2) GCP, WHO TRS, and Mongolia’s pharmaceutical registration requirements.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval variations in Mongolia.
• Media Selection: Biorelevant and pharmacopeial dissolution media.
• Similarity Factor: f2 similarity factor calculation for comparing dissolution profiles.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution comparisons.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in accordance with WHO TRS, ICH Q6A, and Mongolian regulatory expectations.
• IVIVC Modelling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive Modeling: Dissolution–PK correlation to support regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical methodologies.
• Validation: Conducted as per ICH M10, WHO guidelines, and DMME-accepted bioanalytical validation requirements.
• Stability Methods: Stability-indicating method development for APIs and finished drug products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Statistical evaluation of bioequivalence in line with ICH/WHO standards recognized by Mongolian regulators.
• Sample Size Optimization: Power and sample-size calculations suitable for BA/BE requirements.
📑 MOH/DMME-Ready Regulatory Documentation
We prepare full documentation required for pharmaceutical registration with the Department of Medicines and Medical Equipment (DMME), Mongolia, including:
• Clinical Study Protocol (Mongolia-aligned)
• Informed Consent Forms (ICF) per local ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) per ICH + WHO format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Mongolian drug registration
✨ Why Choose BioEquiGlobal for the Mongolian Market?
• Regulatory Alignment: BA/BE protocols, dissolution profiles, and analytical documentation tailored to Mongolia’s registration requirements.
• Quality Assurance: GCP-, GLP-, and WHO-compliant operations with robust SOP-driven quality oversight.
• Modern Infrastructure: Accredited clinical units and high-quality analytical laboratories (NABL-certified where applicable).
• Global Dossier Expertise: Dossiers prepared for MOH Mongolia, as well as US FDA, EMA, GCC, MHRA, TGA, ASEAN, and African authorities.
🗺️ BA/BE Study Workflow for Mongolia
Feasibility & Regulatory Gap Assessment: Review of reference product availability, Mongolian pharmacopeial requirements, and biowaiver eligibility.
Protocol Development: Drafting a Mongolia-compliant BA/BE protocol and supporting IRB approval.
Analytical Method Development: LC-MS/MS method creation and validation following ICH M10 and WHO TRS guidelines.
Clinical Execution: Volunteer recruitment, dosing, sampling, and monitoring under strict GCP compliance.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of MOH/DMME-ready CSR, dissolution reports, analytical validations, and CTD/ACTD dossier modules.
Who We Support
• Mongolian pharmaceutical manufacturers requiring MOH/DMME registration
• Regional CROs needing BA/BE or analytical outsourcing
• Regulatory teams needing Mongolia-compliant CTD/ACTD dossiers