🇳🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for New Zealand

Medsafe-Compliant BA/BE Studies & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies and Comparative Dissolution Profiling, tailored to meet the regulatory requirements of New Zealand’s Medsafe under the Medicines Act 1981 and Medicines Regulations 1984.

All study activities are aligned with:

• Medsafe Guidelines for Bioequivalence of Medicines (New Zealand)

• ICH Guidelines (E6 R2, Q2, Q6A, M10)

• CPMP/EMA BE guidelines (as referenced by Medsafe)

• WHO TRS & internationally harmonized BE recommendations

• GCP, GLP & GMP quality requirements

• USP / Ph. Eur. dissolution standards

New Zealand adopts a scientifically harmonized BE framework closely aligned with EMA and ICH, making high-quality BE studies essential for generic medicine registration.

💊 Core BA/BE Services for New Zealand (Medsafe)

Clinical BA/BE Studies (Human)

• Conducted in accordance with Medsafe’s BE expectations & ICH GCP.
• Single-dose and multiple-dose BE studies using crossover or parallel designs.
• Studies for healthy volunteers or patient-specific populations, as needed.
• Ethical approval through HDEC (Health and Disability Ethics Committees).
• Protocols aligned with ICH E6 (R2) & Medsafe-referenced EMA BE guidelines.

Comparative Dissolution Profiling (CDP)

• Required for registering generics and reformulated products in NZ.
• Dissolution methods per Ph. Eur., USP, and biorelevant media (e.g., FaSSIF/FeSSIF).
• Similarity factor (f2) for dissolution profile comparison.
• Model-dependent & model-independent dissolution analyses.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification following Medsafe/EMA/ICH Q6A standards.
• Level A/B/C IVIVC modelling to correlate dissolution and PK data.
• Biowaivers for qualifying BCS Class I & III drugs where justified.

Analytical Method Development & Validation

• Bioanalytical testing using LC-MS/MS & HPLC-UV.
• Full validation per ICH M10, recognized by Medsafe.
• Stability-indicating methods for APIs & finished dosage forms.
• Validation parameters: accuracy, precision, linearity, selectivity & stability.

Pharmacokinetic (PK) & BE Statistical Evaluation

• Non-compartmental PK analysis of AUC, Cmax, Tmax, t½, etc.
• Standard BE acceptance limits: 90% CI within 80–125%.
• Support for Highly Variable Drugs (HVDs) using scientifically justified approaches.
• Sample-size & power analysis adhering to international BE statistical norms.

📑 Medsafe-Ready CTD Documentation

We prepare complete registration-ready documentation for New Zealand submissions:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with Medsafe + ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5, including:

• New Zealand CTD Module 1 requirements

• Dossier structure for Generic Medicine Applications

• Reformulation or post-approval BE documentation

✨ Why Choose BioEquiGlobal for the New Zealand Market?

• Medsafe-Aligned BE Expertise: Study designs precisely follow NZ guidelines and EMA-accepted principles.
• GCP/GLP/GMP-Compliant Operations: Ensuring global data acceptability.
• Ideal for NZ + Australia (ANZ) Region: BE packages can support submissions to both Medsafe and TGA with minimal adaptation.
• Strong Support for Complex Products: Modified-release, topical, inhalation, ophthalmic, injectables & HVDs.
• Complete End-to-End Service: From BE feasibility, protocol writing & clinical execution to PK/BE evaluation and CTD dossier preparation.

🗺️ BA/BE Study Workflow for New Zealand (Medsafe Submissions)

1. Feasibility & Regulatory Review
   (Reference selection, guideline mapping, biowaiver eligibility)

2. Protocol Development & Ethics Approval (HDEC)
   (NZ clinical trial compliance)

3. Analytical Method Development & Validation
   (ICH M10-compliant LC-MS/MS validation)

4. Clinical BA/BE Study Execution
   (Volunteer recruitment, dosing & PK sampling under GCP)

5. Bioanalysis & PK/BE Statistical Interpretation
   (NCA, BE assessment)

6. Medsafe-Ready CTD Documentation
   (CSR, CDP, validation reports & Module 1–5 dossiers)

Who We Support in New Zealand & Internationally

• NZ generic medicine sponsors
• Global companies submitting to Medsafe
• CROs needing outsourced PK, bioanalytical or BE services
• Innovators reformulating products for NZ
• Export-oriented pharmaceutical companies entering ANZ markets
• Biotech & specialty pharma companies