🇸🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Saudi Arabia
SFDA-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 the Saudi Food and Drug Authority (SFDA).
Our studies strictly follow GCP, GLP, WHO TRS, ICH, and the SFDA Guidelines for Bioequivalence Studies, ensuring full compliance for Saudi Arabian drug registration and GCC regional submissions.
💊 Core Services for Saudi Arabia (SFDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs recognized by SFDA.
• Volunteer Selection: Healthy volunteers or patient groups based on therapeutic class and risk level.
• Ethics Approval: Approval by a certified Institutional Review Board (IRB) in accordance with Saudi National Committee of Bioethics (NCBE) requirements.
• Protocol Development: SFDA-aligned BA/BE protocols developed in accordance with ICH E6 (R2) GCP and WHO TRS guidance.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, variations, and post-approval changes per SFDA guidelines.
• Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Analysis: f2 similarity factor calculation for comparing dissolution profiles of test and reference products.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS Biowaiver: Prepared following SFDA, WHO TRS, and ICH Q6A-aligned biowaiver frameworks.
• IVIVC Modeling: Level A, B, and C models to support predictability and regulatory acceptance.
• Dissolution–PK Analysis: Predictive modeling to justify in vitro–in vivo correlation.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems used for accurate and sensitive drug quantification.
• Validation: Conducted per ICH M10, WHO TRS, and SFDA-recognized validation guidelines.
• Stability-Indicating Methods: Developed for APIs and drug products for dossier compatibility.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA) for BA/BE evaluation.
• BE Statistics: Statistical evaluation aligned with SFDA, ICH, and WHO harmonized methodologies.
• Sample Size Determination: Power analysis and study optimization based on SFDA regulatory requirements.
📑 SFDA-Ready Regulatory Documentation
We prepare complete documentation required for pharmaceutical submissions to the Saudi Food and Drug Authority (SFDA), including:
• Clinical Study Protocol (SFDA- and ICH-aligned)
• Informed Consent Forms (ICF) aligned with NCBE ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) structured according to SFDA and ICH formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for SFDA submissions (SFDA follows CTD format with GCC alignment)
✨ Why Choose BioEquiGlobal for the Saudi Market?
• Saudi Regulatory Expertise: Documentation, protocols, and analytical data aligned with SFDA regulatory expectations.
• Quality Systems: GCP-, GLP-, WHO-, and ICH-compliant processes with robust internal QA oversight.
• Advanced Analytical & Clinical Facilities: High-quality analytical laboratories and accredited clinical units (including NABL-certified labs where applicable).
• Global Submission Capability: Expertise in preparing dossiers for SFDA, as well as US FDA, EMA, MHRA, TGA, GCC, and African authorities.
🗺️ BA/BE Study Workflow for Saudi Arabia
Feasibility & SFDA Gap Assessment: Evaluation of reference product requirements, Saudi market equivalents, and biowaiver eligibility.
Protocol Development: Preparation of SFDA-compliant BA/BE protocols and facilitation of IRB approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 and SFDA guidelines.
Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, and sampling.
Bioanalysis & PK Assessment: PK modeling, QC checks, and statistical BE evaluation.
Documentation & Submission: Preparation of SFDA-ready CSR, dissolution report, validation documents, and CTD Modules 1–5.
Who We Support
• Saudi pharmaceutical manufacturers seeking SFDA approval
• GCC-region CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing SFDA-compliant CTD dossiers