🇨🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Canada

Health Canada–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory expectations of:

• Health Canada

• Therapeutic Products Directorate (TPD)

• Biologic and Genetic Therapies Directorate (BGTD)

All studies comply with Health Canada Comparative Bioavailability Guidelines, ICH requirements, WHO TRS, GCP, and GLP, ensuring regulatory readiness for submissions in Canada.

💊 Core Services for Canada (Health Canada) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & steady-state BE studies (crossover, replicate, parallel) compliant with Health Canada guidance.
• Volunteer Selection: Healthy volunteers or relevant patient cohorts per product-specific considerations.
• Ethics Approval: Mandatory approval from a Health Canada–recognized Research Ethics Board (REB).
• Protocol Development: Developed per Health Canada BA/BE Guidance, ICH E6 (R2), and CSA standards for clinical research.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for pharmaceutical equivalence, post-approval changes, and ANDS/NDS submissions.
• Dissolution Media: USP/bio-relevant media recommended by Health Canada.
• Similarity Factor: f2 similarity factor for comparing dissolution curves.
• Evaluation Models: Includes WHO/ICH-approved model-independent (f1, f2) and model-dependent analyses.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to Health Canada, WHO TRS, and ICH Q6A guidelines.
• IVIVC Models: Level A, B, and C models acceptable to Health Canada.
• Predictive PK Modeling: Supports science-based BE justification and alternative study approaches.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV per Health Canada expectations.
• Validation: Conducted according to Health Canada Bioanalytical Method Validation Guidance, ICH M10, and WHO TRS.
• Stability-Indicating Methods: Developed for APIs and final pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistical Requirements: Health Canada’s acceptance range (typically 80–125% for AUC & Cmax).
• Sample Size & Power: Justified based on intra-subject variability per Health Canada recommendations.

📑 Health Canada–Ready Regulatory Documentation

We prepare complete documentation tailored for Canadian regulatory filing, including:

• Clinical Study Protocol (Canada-compliant)
• Informed Consent Forms (ICF) aligned with REB requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & Health Canada guidance
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules (1–5) formatted for submission to Health Canada (NDS, ANDS, or DIN applications)

✨ Why Choose BioEquiGlobal for the Canadian Market?

• Expertise in Health Canada Guidelines: All BE studies and documentation follow the latest Canadian BA/BE guidance and TPD standards.
• International Quality Compliance: GCP, GLP, WHO TRS, and ICH alignment with strong QA systems.
• Modern Analytical & Clinical Facilities: Accredited clinical centres and state-of-the-art analytical laboratories (including NABL-certified setups).
• Global Submission Capability: CTD dossiers prepared for Canada and international regulators (FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Canada

1. Feasibility & Gap Assessment: Review of reference product availability, Health Canada BE criteria, and biowaiver feasibility.

2. Protocol Development: Health Canada–aligned BA/BE protocol preparation and REB approval coordination.

3. Analytical Method Development: LC-MS/MS assay development & validation per Health Canada and ICH M10.

4. Clinical Study Execution: GCP-driven recruitment, dosing, PK sampling, and medical monitoring.

5. Bioanalysis & PK Evaluation: PK modelling, QC checks, and BE statistical evaluation per Health Canada criteria.

6. Documentation & Submission: Delivery of Health Canada–ready CSR, CDP report, validation documentation, and CTD Modules.

Who We Support

• Companies submitting ANDS/NDS applications to Health Canada
• Generic drug manufacturers targeting the Canadian market
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams requiring Health Canada–compliant CTD dossiers