🇹🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Tonga

Ministry of Health (MOH Tonga)–Aligned BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, tailored for pharmaceutical companies seeking product registration in the Kingdom of Tonga.

Tonga’s Ministry of Health does not maintain standalone BE guidelines; instead, it recognizes internationally accepted regulatory frameworks, including:

• WHO TRS Guidelines for BE Studies

• ICH Guidelines (E6 R2, Q2, Q6A, M10)

• EMA Guideline on the Investigation of Bioequivalence (2010/2022)

• USP / Ph. Eur. Dissolution Standards

• GCP, GLP & GMP global quality practices

This makes high-quality, globally aligned BA/BE packages suitable for Tonga, as well as neighboring Pacific Island regulatory systems.

💊 Core BA/BE Services for Tonga (MOH-Aligned)

Clinical BA/BE Studies (Human)

• Conducted per WHO, ICH, and EMA BE expectations, accepted by Tonga MOH.
• Single-dose & multiple-dose, crossover and parallel designs.
• Healthy volunteer or therapeutic-area-specific patient studies.
• Ethics approvals compliant with international GCP frameworks.
• Protocols developed according to ICH E6 (R2) and WHO-recommended BE principles.

Comparative Dissolution Profiling (CDP)

• Required for generic registration under Tonga’s reliance on international standards.
• Dissolution using USP, Ph. Eur., and biorelevant media.
• Similarity factor (f2) for dissolution profile equivalence.
• Model-dependent & model-independent release profile comparisons.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification following WHO TRS, EMA, and ICH Q6A principles.
• Level A/B/C IVIVC modeling to predict PK performance.
• Supports waiver for BCS Class I & III products.

Analytical Method Development & Validation

• Method development on LC-MS/MS and HPLC-UV platforms.
• Full validation per ICH M10 (recognized globally).
• Stability-indicating methods for API & finished formulations.
• Precision, accuracy, linearity, selectivity & stability assessment.

Pharmacokinetic (PK) & Bioequivalence Statistical Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax).
• BE acceptance range: 80–125% (90% CI) — internationally accepted.
• Scaled BE evaluation for highly variable drugs (HVDs).
• Sample-size optimization based on EMA/ICH-statistical principles.

📑 Tonga Ministry of Health–Ready Documentation

We prepare full documentation packages suitable for Tonga’s reliance-based regulatory system:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) per ICH E3 structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 2–5
• Module 1 adapted to Tonga MOH submission requirements

This documentation can also support filings in other Pacific Island nations (Fiji, Samoa, Vanuatu, Solomon Islands, Kiribati, etc.) due to similar reliance processes.

✨ Why Choose BioEquiGlobal for Tonga?

• Reliance-Compliant BE Data: We generate globally accepted BE packages that meet Tonga’s international standards–based evaluation system.
• WHO/ICH/EMA-Standard Processes: Ensures acceptance across multiple non-ICH jurisdictions in the Pacific region.
• Ideal for Pacific Market Entry: Tonga often accepts foreign reference products and comparative data.
• End-to-End Excellence: From feasibility assessment to final CTD dossier customization.
• Support for Complex Products: Modified-release, topicals, ophthalmic, inhalation, biologically complex formulations.

🗺️ BA/BE Study Workflow for Tonga

1. Feasibility & International Guideline Mapping
   (Reference selection, WHO/ICH alignment, biowaiver potential)

2. Protocol Development & Ethics Approval
   (ICH GCP-compliant protocol for international use)

3. Analytical Method Development & Validation
   (ICH M10-compliant validation)

4. Clinical Study Execution
   (GCP-supervised dosing, sampling & monitoring)

5. Bioanalysis & PK/BE Statistics
   (NCA, BE analysis following WHO/EMA standards)

6. Tonga MOH-Ready Submission Dossier
   (CSR, CDP, validation package & adapted CTD modules)

Who We Support in Tonga & the Pacific Region

• Pharmaceutical manufacturers entering Pacific markets
• Export-oriented generic drug producers
• Companies registering medicines via reliance pathways
• CROs outsourcing BA/BE or bioanalytical work
• Innovators reformulating products for regional submissions