🇯🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Jordan
JFDA-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 services tailored to the regulatory requirements of the Jordan Food & Drug Administration (JFDA).
All studies follow ICH, WHO TRS, GCP, GLP, and the JFDA Guidelines for Bioequivalence Studies, ensuring full compliance for pharmaceutical registration in Jordan and international markets.
💊 Core Services for Jordan (JFDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by JFDA.
• Volunteer Selection: Healthy volunteer or patient-based studies depending on therapeutic area and JFDA guidance.
• Ethics Approval: Approval by a recognized Institutional Review Board (IRB)/Ethics Committee in accordance with Jordanian ethical regulations.
• Protocol Development: JFDA-aligned protocols built on ICH E6 (R2) GCP, WHO TRS, and global BA/BE standards.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and variations as per JFDA.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media to match JFDA specifications.
• Similarity Factor: Evaluation of f2 similarity factor for test vs. reference product comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed per WHO TRS, ICH Q6A, and JFDA-recognized frameworks.
• IVIVC Modeling: Level A, B, and C models for in vitro–in vivo predictability.
• Predictive Modeling: Dissolution–PK relationship modeling for regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for quantitative drug analysis.
• Validation: In accordance with ICH M10, WHO TRS, and JFDA expectations.
• Stability-Indicating Methods: For APIs and finished products to support regulatory submission.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA) for BA/BE evaluation.
• BE Statistics: Statistical comparison based on ICH and WHO harmonized bioequivalence requirements.
• Sample Size Determination: Power analysis and design optimization meeting JFDA criteria.
📑 JFDA-Ready Regulatory Documentation
We prepare all required pharmaceutical registration documents for submission to the Jordan Food & Drug Administration (JFDA):
• Clinical Study Protocol (JFDA-aligned methodology)
• Informed Consent Forms (ICF) per Jordanian ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) structured as per ICH and WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for JFDA drug registration requirements
✨ Why Choose BioEquiGlobal for the Jordanian Market?
• JFDA-Focused Expertise: Protocols, dissolution studies, PK analysis, and documentation tailored to Jordan’s regulatory framework.
• Quality Compliance: GCP- and GLP-aligned operations with internal QA oversight.
• Advanced Infrastructure: Accredited clinical units and high-standard analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Strength: Preparation of dossiers for JFDA as well as US FDA, EMA, GCC, MHRA, TGA, and other international agencies.
🗺️ BA/BE Study Workflow for Jordan
Feasibility & Regulatory Gap Assessment: Evaluation of Jordanian reference products, JFDA guidance, and biowaiver potential.
Protocol Development: Drafting JFDA-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 Study Execution: GCP-monitored dosing, sampling, and safety assessments.
Bioanalysis & PK Assessment: QC-verified bioanalysis, PK computation, and BE statistics.
Documentation & Submission: Preparation of JFDA-ready CSR, dissolution reports, validation data, and CTD/ACTD regulatory modules.
Who We Support
• Jordanian pharmaceutical manufacturers seeking JFDA registration
• CROs requiring BA/BE study outsourcing or analytical support
• Regulatory departments needing JFDA-compliant CTD/ACTD dossiers