🇮🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Iran
IFDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of the Iran Food & Drug Administration (IFDA).
All studies fully comply with GCP, GLP, WHO TRS, ICH guidelines, and IFDA’s pharmaceutical registration requirements, ensuring suitability for national approvals and international regulatory submissions.
💊 Core Services for Iran (IFDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs per IFDA guidelines.
• Volunteer Selection: Healthy volunteers or patient groups as appropriate to the drug class and IFDA expectations.
• Ethics Approval: Approval by recognized Ethics Committees (IRB) under the Ministry of Health & Medical Education (MOHME).
• Protocol Design: IFDA-aligned protocols based on ICH E6 (R2) GCP and WHO TRS recommendations.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic drug registration and post-approval variations per IFDA expectations.
• Dissolution Media: Biorelevant and pharmacopeial media suitable for Iranian regulatory submissions.
• Similarity Factor: f2 similarity factor evaluation for dissolution comparison.
• Methods: Model-independent (f1, f2) and model-dependent analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH, and IFDA-recognized scientific principles.
• IVIVC Models: Level A, B, and C modeling to support product predictability.
• Dissolution–PK Modeling: Predictive performance simulations to support regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical workflows for sensitive drug quantification.
• Validation: Performed as per ICH M10, WHO TRS, and IFDA-accepted guidelines.
• Stability Studies: Stability-indicating method development for APIs and formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA) for BE determination.
• Statistical Evaluation: BE statistics using methodologies aligned with ICH/WHO and accepted by IFDA.
• Study Design Optimization: Power and sample-size calculations tailored to IFDA regulatory expectations.
📑 IFDA-Ready Regulatory Documentation
We prepare all documents required for pharmaceutical product submissions to the Iran Food & Drug Administration (IFDA):
• Clinical Study Protocol (IFDA-aligned)
• Informed Consent Forms (ICF) adapted to Iranian ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules for IFDA drug registration requirements
✨ Why Choose BioEquiGlobal for the Iranian Market?
• IFDA-Focused Expertise: Protocols and documentation tailored to Iran’s pharmaceutical regulations and internationally harmonized guidelines.
• Quality Compliance: GCP- and GLP-aligned operations with strong internal QA oversight.
• Advanced Facilities: Accredited clinical units and high-precision analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Support: Dossier development for IFDA as well as US FDA, EMA, GCC, MHRA, TGA, ASEAN regulators, and African agencies.
🗺️ BA/BE Study Workflow for Iran
Feasibility & IFDA Gap Assessment: Review of Iranian reference product availability, BCS class, and biowaiver potential.
Protocol Development: Drafting IFDA-appropriate BA/BE protocols and securing ethical approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and WHO standards.
Clinical Study Execution: Volunteer dosing, sampling, and safety monitoring under strict GCP compliance.
Bioanalysis & PK Assessment: Bioanalytical testing, PK evaluation, and statistical BE calculations.
Documentation & Submission: Finalizing CSR, validation reports, dissolution results, and CTD/ACTD submission modules for IFDA.
Who We Support
• Iranian pharmaceutical manufacturers seeking IFDA drug registration
• CROs in Iran needing outsourced BA/BE or analytical support
• Regulatory teams requiring IFDA-compliant CTD/ACTD dossiers