🇹🇼 Bioavailability & Bioequivalence (BA/BE) Studies Services for Taiwan

TFDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., offers complete Bioavailability/Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) designed specifically for Taiwan’s TFDA regulatory framework.

All studies strictly follow TFDA guidelines, ICH, WHO TRS, GCP, and GLP requirements — supporting pharmaceutical companies seeking generic drug approvals and variations in Taiwan.

💊 Our Core Services for Taiwan (TFDA) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Types: Single-dose & multiple-dose; crossover & parallel study designs as accepted by TFDA.

• Volunteer Selection: Healthy volunteer and patient-based studies meeting TFDA clinical safety requirements.

• Ethics Oversight: Approval from TFDA-recognized Institutional Review Board (IRB) / Human Research Ethics Committee (HREC).

• Study Protocol: Designed according to TFDA BA/BE Guidance, ICH E6 (R2), ICH M9, and international GCP principles.

Comparative Dissolution Profiling (CDP)

• Requirement: Mandatory for TFDA generic drug submissions, new formulation changes, and post-approval variations.

• Medium Selection: Standard & biorelevant dissolution media based on TFDA and ICH recommendations.

• Similarity Evaluation: f2 similarity factor, model-dependent, and model-independent comparisons.

• Output: Fully TFDA-aligned CDP statistical and graphical analysis.

IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared according to TFDA BCS Guidance, ICH Q6A, and WHO principles.

• IVIVC Models: Level A, B, and C IVIVC modeling.

• Predictive Tools: PK–dissolution relationship evaluation suitable for TFDA review.

Analytical Method Development & Validation

• Techniques: LC-MS/MS and HPLC-UV platforms.

• Validation Standards: Fully compliant with ICH M10 and TFDA’s bioanalytical method validation requirements.

• Stability Studies: API and finished product stability-indicating method development.

Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Approach: Non-compartmental analysis (NCA).

• BE Statistics: Confidence interval evaluation, ANOVA models, and TFDA-accepted BE assessment metrics.

• Sample Size Calculation: Power-based analysis in line with TFDA recommendations.

📑 TFDA-Ready Regulatory Documentation

We prepare complete document packages compatible with TFDA’s electronic submission and CTD format.

Includes:

• Clinical Study Protocol

• Informed Consent Forms (Chinese & English as required by TFDA)

• Investigator’s Brochure

• Clinical Study Report (CSR) in TFDA structure

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD/ACTD Modules formatted for Taiwan’s drug registration system

• Required TFDA submission templates for generics (ANDA-equivalent)

✨ Why Choose BioEquiGlobal for Taiwan?

• Regulatory Specialization: Expertise in TFDA BA/BE guidelines, BCS classification rules, and Taiwan-specific dossier expectations.

• Quality & Compliance: All operations under GCP, GLP, ICH standards and audited SOP-driven workflows.

• Global Laboratory & Clinical Network: Access to accredited clinical units and validated bioanalytical laboratories.

• International Reach: Ability to prepare parallel dossiers for TFDA, US FDA, EMA, TGA, MHRA, GCC, and other regulatory bodies.

🗺️ Our BA/BE Study Workflow for Taiwan

1. Feasibility Review & TFDA Gap Assessment

Evaluation of the reference product, BCS classification, and Taiwan-specific regulatory needs.

2. Protocol Development & IRB Approval

TFDA-compliant protocol preparation; ethics approval from recognized IRBs/HRECs.

3. Analytical Method Development

LC-MS/MS assay development & ICH M10 validation.

4. Clinical Study Execution

Volunteer recruitment, dosing, sampling, and safety monitoring under strict GCP standards.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical testing, PK modelling, and TFDA-compatible BE statistical analysis.

6. Documentation & TFDA Submission Support

CSR preparation, CDP reporting, and CTD module assembly for TFDA review.

Who We Support in Taiwan

• Generic pharmaceutical manufacturers applying for TFDA approval.

• Companies expanding into Taiwan + Southeast Asia with harmonized CTDs.

• CROs outsourcing analytical or clinical BA/BE activities.

• Regulatory teams preparing TFDA dossiers or managing lifecycle submissions.