Bioavailability & Bioequivalence (BA/BE) Studies Services – Globally

Fast, reliable, regulatory-ready BA/BE studies & comparative dissolution profiles

BioEquiGlobal by Zoesoe Exports Pvt Ltd delivers end-to-end bioavailability (BA) and bioequivalence (BE) study services and comparative dissolution profiling for generic and innovator products. We combine regulatory expertise, GLP/GCP-compliant facilities, and industry-proven analytical methods to help you achieve market approvals across global jurisdictions.

Our core services

• Clinical BA/BE Studies (Human) — Single-dose, multiple-dose, crossover and parallel designs; healthy volunteer and patient studies as required.

• Comparative Dissolution Profiling — Biorelevant and routine dissolution methods (sink, non-sink) with similarity (f2) and model-independent/model-dependent analyses.

• In Vitro–In Vivo Correlation (IVIVC) — Level A/B/C correlations and predictive modeling to support biowaiver strategies.

• Analytical Method Development & Validation — LC-MS/MS, HPLC-UV, and stability-indicating methods validated per ICH and regulatory guidance.

• Pharmacokinetic (PK) Analysis & Reporting — Non-compartmental analysis, statistical bioequivalence analysis, and power/sample-size calculations.

• Regulatory Dossier Preparation — Full study reports, clinical study reports (CSR), and submission-ready modules (ICH/CTD format) for CDSCO, US FDA, EMA, and other global regulators.

• GCP/GLP Compliance & Quality Assurance — Internal QA audits, SOPs, monitoring, and data integrity controls.

Why choose BioEquiGlobal?

• Regulatory-first approach — Studies designed to meet the expectations of CDSCO, US FDA, EMA and other regulatory authorities.

• Experienced multidisciplinary team — Clinical pharmacologists, biostatisticians, analytical chemists, regulatory writers and QA experts.

• State-of-the-art facilities — Accredited clinical units, certified analytical labs, temperature-controlled sample storage and validated bioanalytical platforms.

• Transparent project management — Dedicated project manager, milestone tracking, and timely communication throughout the study lifecycle.

• Cost-effective and timelines-focused — Optimized study designs that balance statistical power with practical timelines and budgets.

• Data integrity & security — Audit trails, secure storage, and full traceability for raw data and QC.

Our study workflow

1. Project feasibility & regulatory gap analysis — Product attributes, reference selection, and biowaiver assessment.

2. Protocol development & regulatory strategy — Clinical protocol, statistical analysis plan, and ethics/regulatory submissions.

3. Method development & validation — Bioanalytical method validated as per regulatory guidance.

4. Clinical conduct — Volunteer recruitment, dosing, sample collection, and clinical oversight under GCP.

5. Bioanalysis & PK analysis — Quantification, QA review, and pharmacokinetic/statistical analysis.

6. Report & submission — CSR, comparative dissolution reports, and CTD-ready documents.

Comparative Dissolution: how we deliver confidence

• Use of biorelevant media and physiologically based dissolution testing when appropriate.

• Robust similarity testing (f2) plus complementary model-based comparisons.

• Detailed dissolution method transfer and troubleshooting to ensure reproducibility across batches and labs.

• Integration of dissolution data with PK results to support biowaiver claims and regulatory discussions.

Regulatory & quality compliance

BioEquiGlobal adheres to:

• Good Clinical Practice (GCP)

• Good Laboratory Practice (GLP) where applicable

• ICH guidelines (M4, M9 for BE/BA)

• Local regulatory requirements (CDSCO, DCGI), and can prepare dossiers for US FDA, EMA, and other global agencies.

Who we work with

• Generic pharmaceutical companies seeking product approvals.

• Innovator companies requiring comparative profiling or PK bridging studies.

• CROs and formulation developers needing bioanalytical or dissolution expertise.

• Regulatory teams needing submission-ready documentation.

Fast facts

• Clinical units: Phlebotomy, monitoring, emergency response, and comfortable volunteer stay facilities.

• Analytical platforms: LC-MS/MS, HPLC, validated sample preparation workflows.

• Deliverables: Protocol, CSR, validated method reports, statistical reports, comparative dissolution profiles, CTD-ready modules.

“Bioequivalence Delivered. Approvals Accelerated.”

Excellence in BA/BE & CDP Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Bioavailability & Bioequivalence (BA/BE) Studies Services

Frequently Asked Questions (FAQ)

BioEquiGlobal — A Brand of Zoesoe Exports Pvt Ltd

1. What services does BioEquiGlobal provide?

BioEquiGlobal specializes in Bioavailability (BA) studies, Bioequivalence (BE) studies, Comparative Dissolution Profiling, Analytical Method Validation, Pharmacokinetic (PK) analysis, and CTD-ready regulatory documentation for global submissions.

2. What is a Bioequivalence (BE) study?

A BE study compares a test product with a reference/innovator product to determine if they deliver the same amount of active ingredient into the bloodstream in the same time frame. Regulatory authorities require BE studies for generic drug approvals.

3. What is the difference between Bioavailability (BA) and Bioequivalence (BE)?

• Bioavailability measures how much and how fast a drug reaches systemic circulation.

• Bioequivalence compares two products to ensure they have similar bioavailability.
  BE is essential for generics; BA is often used during formulation development.

4. Do you conduct BA/BE studies in compliance with global regulations?

Yes. All studies follow ICH, GCP, GLP, and country-specific guidelines required for CDSCO, US FDA, EMA, GCC, TGA, and other global agencies.

5. What is included in a Comparative Dissolution Profile study?

Our dissolution studies include:

• Biorelevant or standard media selection

• Dissolution method optimization

• Multi-point profiling

• Similarity factor (f2) testing

• Model-dependent and model-independent comparisons

• Full analytical and statistical reporting

6. How long does it take to complete a BA/BE study?

Timelines depend on study design and regulatory requirements, but an average project may take:

• Protocol + approvals: 2–4 weeks

• Clinical phase: 1–3 weeks

• Bioanalysis + PK/Stat: 4–6 weeks

• CSR & CTD docs: 1–2 weeks
  Total: 8–14 weeks (varies by product)

7. What information do you need to provide a quote?

To start feasibility and costing, please share:

• Dosage form & strength

• Innovator/reference product details

• Intended regulatory markets

• Expected timelines

• Any existing analytical methods/dissolution data

8. Can BioEquiGlobal prepare CTD/ICH submission documents?

Yes. We provide complete regulatory writing services:

• Clinical Study Reports (CSR)

• Bioanalytical Method Validation Reports

• Statistical Analysis Reports

• CTD Modules (Module 1, 2, 5 for BA/BE studies)

9. Do you offer biowaiver support?

Yes. For eligible BCS Class I & III products, BioEquiGlobal supports:

• BCS classification

• Comparative dissolution

• Biowaiver justification

• Regulatory documentation for waiver submission

10. Is volunteer safety ensured during clinical studies?

Absolutely. BA/BE studies are conducted in GCP-compliant accredited facilities, with:

• Ethical committee approval

• Medical supervision

• Controlled hospitalization

• Emergency response systems

• Informed consent process

11. Do you offer method development and LC-MS/MS bioanalysis?

Yes. Our bioanalytical facility conducts:

• LC-MS/MS assay development

• Calibration curve & QC validation

• Stability studies

• Sample analysis with QA oversight

12. What types of dosage forms do you handle?

We manage BA/BE and dissolution studies for:

• Tablets, capsules, granules

• Oral liquids, suspensions

• Modified-release formulations

• Semi-solids & topical products (in vitro/in vivo as per guidelines)

• Special category products as per regulatory pathways

13. Can you handle global clients?

Yes. BioEquiGlobal supports clients from India, Asia-Pacific, Middle East, Africa, Europe, and Latin America, providing export-ready regulatory documentation and study support.

14. What makes BioEquiGlobal different from other CROs?

• Regulatory-first study design

• Advanced analytical platforms

• Transparent timelines & communication

• Dedicated project manager for each study

• End-to-end coverage from feasibility to submission

• Cost-effective solutions without compromising quality