🇨🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Asia

BioEquiGlobal – Asia

BA/BE Studies & Comparative Dissolution Services for Asian Regulatory Markets

Fast. Reliable. Regulatory-Ready Bioequivalence Studies.

BioEquiGlobal, a scientific service platform of Zoesoe Exports Pvt Ltd, provides end-to-end Bioavailability (BA) and Bioequivalence (BE) study services along with comparative dissolution profiling for pharmaceutical products targeting Asian regulatory markets.

We support pharmaceutical manufacturers, exporters, and formulation developers seeking approvals across ASEAN, South Asia, and other Asian MOH jurisdictions through GCP-compliant clinical studies, validated bioanalytical methods, and regulatory-ready documentation.

Our integrated approach combines clinical research, bioanalytical expertise, pharmacokinetics, and regulatory strategy to ensure smooth approvals across Asia.

Our Core Services

✅ Clinical BA/BE Studies (Human)

• Single-dose and multiple-dose studies
• Crossover and parallel study designs
• Studies in healthy volunteers or patient populations (as required)
• Clinical conduct under Good Clinical Practice

These studies support generic drug approvals and regulatory submissions across Asian markets.

✅ Comparative Dissolution Profiling

• Routine dissolution testing
• Biorelevant dissolution media
• Sink and non-sink dissolution conditions

Data analysis includes:

• Similarity factor (f2) comparison
• Model-independent analysis
• Model-dependent dissolution modeling

These studies are essential for biowaiver strategies and formulation equivalence evaluation.

✅ In Vitro – In Vivo Correlation (IVIVC)

• Level A, Level B and Level C IVIVC models
• Predictive dissolution modeling
• Support for biowaiver justification

IVIVC helps reduce regulatory risk and supports efficient product lifecycle management.

✅ Bioanalytical Method Development & Validation

Validated analytical methods using:

• LC-MS/MS platforms
• HPLC-UV methods
• Stability-indicating analytical techniques

All methods validated in compliance with ICH M9 and Asian regulatory expectations.

✅ Pharmacokinetic (PK) Analysis & Statistical Evaluation

• Non-compartmental pharmacokinetic analysis
• Bioequivalence statistical evaluation
• Power and sample size calculations
• Regulatory statistical reporting

✅ Regulatory Dossier Preparation

BioEquiGlobal provides submission-ready documentation including:

• Clinical Study Protocols
• Clinical Study Reports (CSR)
• Comparative dissolution reports
• Bioanalytical method validation reports
• ACTD / CTD submission modules

For regulatory authorities including:

• Central Drugs Standard Control Organization
• ASEAN regulatory authorities
• National Ministries of Health across Asia

GCP / GLP Compliance & Quality Assurance

All studies are conducted following international quality standards including:

• Good Clinical Practice
• Good Laboratory Practice

Quality assurance includes:

• Internal QA audits
• SOP-based operations
• Data integrity monitoring
• Regulatory inspection readiness

Why Choose BioEquiGlobal?

✔ Regulatory-focused study design aligned with Asian authorities
✔ Experienced multidisciplinary scientific team
✔ Accredited clinical units and validated bioanalytical laboratories
✔ Dedicated project management and milestone tracking
✔ Cost-effective study execution
✔ Strong data integrity and documentation control

Our Study Workflow

BioEquiGlobal follows a structured study lifecycle to ensure regulatory success:

1️⃣ Project Feasibility & Regulatory Gap Analysis

• Product assessment
• Reference product selection
• Biowaiver feasibility evaluation

2️⃣ Protocol Development & Regulatory Strategy

• Clinical study protocol
• Statistical analysis plan
• Ethics committee and regulatory submissions

3️⃣ Method Development & Validation

• Bioanalytical method development
• Validation according to regulatory guidance

4️⃣ Clinical Study Conduct

• Volunteer recruitment
• Dosing and clinical monitoring
• Blood sample collection and handling

5️⃣ Bioanalysis & PK Analysis

• Sample quantification
• Pharmacokinetic analysis
• Statistical bioequivalence evaluation

6️⃣ Study Reports & Regulatory Submission

• Clinical Study Report (CSR)
• Comparative dissolution study report
• ACTD / CTD ready documentation

Comparative Dissolution: Our Scientific Approach

BioEquiGlobal provides robust dissolution comparison through:

• Biorelevant dissolution media when required
• Physiologically relevant dissolution testing
• Similarity factor (f2) analysis
• Model-based dissolution comparisons
• Integration of dissolution and PK data

These approaches support biowaivers, formulation development, and regulatory approvals.

Regulatory & Quality Compliance

BioEquiGlobal operates in alignment with:

• International Council for Harmonisation guidelines
• ICH M9
• Asian MOH regulatory requirements
• ACTD submission standards
• National regulatory frameworks across Asia

Who We Work With

BioEquiGlobal supports:

• Generic pharmaceutical manufacturers
• Pharmaceutical exporters targeting Asian markets
• Contract research organizations (CROs)
• Formulation development companies
• Regulatory consulting organizations

Asia Market Coverage

BioEquiGlobal supports BA/BE studies and regulatory submissions for pharmaceutical products targeting Asian markets including:

🇮🇳 India
🇹🇭 Thailand
🇻🇳 Vietnam
🇲🇾 Malaysia
🇵🇭 Philippines
🇮🇩 Indonesia
🇸🇬 Singapore
🇰🇷 South Korea
🇯🇵 Japan
🌏 ASEAN and other Asian MOH jurisdictions

Fast Facts

Clinical Units

• Phlebotomy and clinical monitoring facilities
• Emergency response readiness
• Comfortable volunteer accommodation

Analytical Platforms

• LC-MS/MS systems
• HPLC systems
• Validated bioanalytical sample preparation workflows

Deliverables

• Study protocol
• Clinical Study Report (CSR)
• Bioanalytical validation reports
• Statistical PK analysis reports
• Comparative dissolution profiles
• ACTD / CTD submission modules

Partner with BioEquiGlobal

Accelerate generic drug approvals across Asian regulatory markets with scientifically robust and regulatory-ready BA/BE studies.

From clinical studies to regulatory submissions, BioEquiGlobal is your trusted partner for Asia-focused pharmaceutical development and approvals.