🇬🇧 Bioavailability & Bioequivalence (BA/BE) Studies Services for the United Kingdom

MHRA-Compliant BA/BE Studies, Dissolution Profiling & UK-Ready Dossier Support — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, fully aligned with the regulatory framework of the United Kingdom under the MHRA.

All services comply with:

• MHRA (UK) Bioequivalence & Clinical Trial Requirements (Post-Brexit)

• UK Regulations for Clinical Trials (UK SI 2004/1031 & amendments)

• UK-specific BE guidance (aligned with EMA 2010/2022 where adopted)

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

• GCP, GLP & GMP (UK-compliant)

• British Pharmacopoeia (BP) & European Pharmacopoeia (Ph. Eur.)

The UK continues to follow most EMA scientific standards but operates under its own post-Brexit regulatory systems, making tailored compliance essential.

💊 Core BA/BE Services for the UK Market

Clinical BA/BE Studies (Human)

• Conducted per MHRA and GCP requirements.
• Single-dose & multiple-dose BE studies (crossover or parallel).
• Healthy volunteer and patient-based pharmacokinetic studies.
• Ethical approval via UK Research Ethics Committees (REC).
• Protocols developed in line with MHRA expectations & ICH E6 (R2).
• Incorporation of UK-specific regulatory considerations post-Brexit.

Comparative Dissolution Profiling (CDP)

• Required for generic and hybrid applications (UK national procedure).
• Dissolution methods per BP, Ph. Eur., USP and biorelevant media.
• Similarity factor (f2) analysis for dissolution equivalence.
• Kinetic/model-independent release profile assessments.

IVIVC & Biowaiver Support

• BCS-based biowaiver following MHRA-accepted EMA principles & ICH Q6A.
• Level A/B/C IVIVC modeling for PK-predictive dissolution methods.
• Strength biowaivers for appropriately justified products.

Analytical Method Development & Validation

• LC-MS/MS & HPLC-UV analytical method development.
• Full validation in line with ICH M10, accepted by the MHRA.
• Stability-indicating methods for APIs & finished products.
• Robust evaluation: precision, accuracy, stability, linearity & selectivity.

Pharmacokinetic (PK) & Statistical BE Analysis

• Non-compartmental PK analysis (AUC, Cmax, Tmax, t½).
• BE acceptance criteria typically follow 80.00–125.00% (90% CI).
• Support for Highly Variable Drugs (HVDs) using scaling when scientifically justified.
• PK modeling, variability analysis, and sample-size optimization.

📑 MHRA-Ready Regulatory Documentation

We prepare submission-ready documentation fully aligned with MHRA requirements:

• Clinical Study Protocol
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) following ICH E3 & MHRA structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• UK CTD Modules 1–5 for:

• UK National applications (generic & hybrid)

• PL (Product License) submissions

• Post-approval variations requiring BE data

✨ Why Choose BioEquiGlobal for the United Kingdom?

• Post-Brexit Regulatory Expertise: We design UK-specific BA/BE protocols reflecting MHRA guidance and divergence from EMA where applicable.
• High Compliance Standards: GCP-, GLP-, and GMP-aligned processes ensure UK and global acceptability.
• Strong Scientific Rigor: Analytical, clinical & PK services meet the UK's high data quality expectations.
• Support for All UK Pathways: Including generics, hybrids, reformulations & OTC products requiring BE justification.
• End-to-End Support: From feasibility assessment to final CTD/PL dossier preparation.

🗺️ BA/BE Study Workflow for the United Kingdom

1. Feasibility & MHRA Gap Assessment
   (Reference product review, BE strategy, UK-specific considerations)

2. Protocol Development & UK Ethics Approval (REC)
   (Compliance with UK Clinical Trial Regulations)

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

4. Clinical Study Execution
   (GCP-supervised volunteer recruitment, dosing, sampling & safety monitoring)

5. PK & Statistical BE Evaluation
   (NCA, BE statistics, scaled BE where applicable)

6. MHRA Submission Documentation (CTD Modules)
   (CSR, CDP, validation reports, and full CTD Modules 1–5)

Who We Support in the UK Market

• Generic medicine manufacturers
• Hybrid application sponsors (505(b)(2)-equivalent pathways in UK)
• CROs outsourcing PK/bioanalytical services
• R&D teams reformulating PL-authorized medicines
• Export-oriented pharmaceutical companies entering the UK
• Biotech & specialty pharma innovators