🇸🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Singapore
HSA-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 Singapore’s Health Sciences Authority (HSA).
All studies strictly follow ICH, WHO TRS, GCP, GLP, and HSA’s Guidelines on the Registration of Therapeutic Products, ensuring compliance for Singapore submissions and global markets.
💊 Core Services for Singapore (HSA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by HSA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on the product’s therapeutic class.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB) in Singapore, following the Human Biomedical Research Act (HBRA).
• Protocol Development: HSA-aligned protocols built on ICH E6 (R2) GCP, WHO TRS, and international BE guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration and post-approval changes under HSA regulations.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: Calculation of f2 similarity factor for comparing dissolution profiles.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and HSA-recognized scientific principles.
• IVIVC Modeling: Level A, B, and C modeling approaches.
• Predictive PK Modeling: Dissolution–PK modeling to support regulatory justification.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for high-precision drug analysis.
• Validation: Conducted as per ICH M10, WHO TRS, and validation principles accepted by HSA.
• Stability Methods: Development of stability-indicating methods for APIs and drug products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA).
• Statistical BE Analysis: Statistical BE calculations following ICH and WHO guidelines accepted by HSA.
• Sample Size & Power: Determined using internationally harmonized methods.
📑 HSA-Ready Regulatory Documentation
We prepare complete regulatory documentation for submission to the Health Sciences Authority (HSA) Singapore, including:
• Clinical Study Protocol (Singapore/HSA-compliant)
• Informed Consent Forms (ICF) aligned with HBRA and IRB guidelines
• Investigator Brochure
• Clinical Study Report (CSR) per ICH/WHO TRS structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for HSA’s Therapeutic Product Registration
✨ Why Choose BioEquiGlobal for the Singapore Market?
• HSA-Focused Expertise: All BE protocols, analytical reports, and CTD modules tailored to Singapore’s regulatory requirements.
• High Compliance Standards: GCP-, GLP-, WHO- and ICH-driven processes with strong QA oversight.
• Advanced Infrastructure: Accredited clinical facilities and high-performance analytical laboratories (including NABL-certified labs where applicable).
• International Dossier Strength: Dossiers prepared for HSA as well as US FDA, EMA, MHRA, TGA, GCC, ASEAN, and African regulatory authorities.
🗺️ BA/BE Study Workflow for Singapore
Feasibility & Regulatory Gap Assessment: Evaluation of reference product availability, BCS biowaiver eligibility, and HSA-specific requirements.
Protocol Development: Drafting HSA-compliant BA/BE protocols and facilitating IRB approval.
Analytical Method Development: LC-MS/MS method creation and validation following ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored subject recruitment, dosing, and sample collection.
Bioanalysis & PK Assessment: PK modeling, QC verification, and BE statistical evaluation.
Documentation & Submission: Preparation of HSA-ready CSR, dissolution profiles, validation reports, and CTD modules (1–5).
Who We Support
• Singapore-based pharmaceutical companies seeking HSA product registration
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing HSA-compliant CTD dossiers