PSUR Central – Thailand
Thai FDA–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of the Thailand Food and Drug Administration (Thai FDA).
All studies strictly follow Thai FDA Bioequivalence Guidelines, ICH, WHO TRS, GCP, GLP, and ASEAN harmonized requirements to ensure compliance for Thailand’s drug registration and international submissions.
💊 Core Services for Thailand (Thai FDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by Thai FDA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic context.
• Ethics Approval: Approval from a Thai Institutional Review Board (IRB) accredited under national biomedical research ethics.
• Protocol Development: Thai FDA–aligned protocols based on ICH E6 (R2) GCP, WHO TRS, and ASEAN BE guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration and post-approval variations in Thailand.
• Dissolution Media: Pharmacopeial and biorelevant media suitable for ASEAN submissions.
• Similarity Factor: Calculation of f2 similarity factor to compare test and reference profiles.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent mathematical modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed in alignment with WHO TRS, ICH Q6A, and Thai FDA-supported scientific approaches.
• IVIVC Modeling: Level A, B, and C IVIVC models.
• Predictive PK Modeling: Used to justify expected in vivo drug performance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted per ICH M10, WHO TRS, and standards recognized by Thai FDA.
• Stability Methods: Stability-indicating methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Modeling: Non-compartmental analysis (NCA).
• BE Statistical Assessment: Aligned with Thai FDA, ICH, and WHO harmonized BE standards.
• Sample Size & Power: Calculated using international BE study methodologies.
📑 Thai FDA–Ready Regulatory Documentation
We prepare full regulatory documentation required for pharmaceutical submission to the Thailand Food and Drug Administration, including:
• Clinical Study Protocol (Thai FDA–compliant)
• Informed Consent Forms (ICF) aligned with Thai IRB requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH/WHO TRS standards
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Thai FDA drug registration
✨ Why Choose BioEquiGlobal for the Thailand Market?
• Thai Regulatory Expertise: BA/BE protocols, analytical reports, and CTD modules tailored to Thai FDA expectations.
• Quality and Compliance: GCP-, GLP-, WHO-, and ICH-based systems with strong internal QA processes.
• State-of-the-Art Facilities: Accredited clinical units and high-quality analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Strength: Dossiers prepared for Thai FDA as well as US FDA, EMA, MHRA, TGA, GCC, ASEAN, and African regulators.
🗺️ BA/BE Study Workflow for Thailand
Feasibility & Gap Assessment: Review of reference product availability, dissolution methods, and biowaiver eligibility.
Protocol Development: Drafting of Thai FDA–compliant BA/BE protocols and assistance with IRB approval.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS guidelines.
Clinical Execution: GCP-supervised volunteer recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of Thai FDA–ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Thai pharmaceutical manufacturers seeking Thai FDA approval
• CROs requiring BA/BE, bioanalytical, or documentation outsourcing
• Regulatory teams needing Thai FDA–compliant CTD/ACTD dossiersPSUR Preparation & Review Services
Thai FDA | US FDA | EU | WHO | PIC/S Compliant
PSUR Central is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Periodic Safety Update Report (PSUR) Preparation and Review Services for Thailand-based pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), and product license holders supplying to the Thai market and regulated international destinations.
Since 2008, PSUR Central has supported pharmaceutical companies worldwide with regulatory-compliant, authority-acceptable PSUR documentation, enabling smooth Food and Drug Administration (Thai FDA) compliance, uninterrupted product renewals, and effective post-marketing safety management.
Who We Support in Thailand
PSUR Central works closely with:
• Thai pharmaceutical manufacturers and MAHs
• Licensed importers, local agents, and distributors registered with Thai FDA
• Companies exporting from Thailand to US, EU, ASEAN, GCC, Africa & LATAM
• Firms managing post-marketing safety obligations under Thai FDA
• Regulatory Affairs (RA) and Pharmacovigilance (PV) teams
• Companies preparing PSURs for renewals, variations, and routine safety submissions
Our services are designed to meet Thailand regulatory requirements while fully aligning with international pharmacovigilance expectations.
Our PSUR Services – Thailand
We provide complete lifecycle support for PSUR documentation, including:
• PSUR preparation as per Thai FDA and country-specific requirements
• PSURs aligned with US FDA, EU, WHO, PIC/S & importing country MOHs
• Independent technical and regulatory review of existing PSURs
• Support for Thai FDA authority queries post-submission
• Safety data gap assessment against current global PV guidelines
• Customization of PSURs based on product type, approval status, and target markets
• Supply of Thai FDA–acceptable, ready-to-use PSUR templates
All PSURs are science-driven, non-generic, and authority-ready.
Regulatory Standards Followed
Our PSUR documentation is prepared in alignment with:
• ICH E2C (R2) Guidelines
• EU GVP Module VII
• WHO Pharmacovigilance Guidelines
• US FDA post-marketing safety requirements
• PIC/S-aligned regulatory frameworks
• Thai FDA pharmacovigilance requirements
• Country-specific formats and reporting timelines
Product Types & Therapeutic Coverage
• Prescription pharmaceutical products
• Over-the-counter (OTC) medicines
• Fixed-Dose Combinations (FDCs)
• APIs (where applicable)
• Traditional and herbal medicines (subject to Thai FDA acceptance)
Why Thai Companies Choose PSUR Central
• Regulatory-focused, globally acceptable PSURs
• Templates accepted across multiple international markets
• Strong expertise in Thai FDA and global authority interactions
• Robust safety data evaluation and signal detection
• Reduced regulatory observations and follow-ups
• Confidential, professional, deadline-driven execution
• Deep understanding of Thailand’s regulatory and ASEAN export environment
How We Support You
To initiate PSUR preparation or review, we typically require:
• Product registration and approval details
• Approved labeling (SmPC / PI)
• Sales and patient exposure data
• Adverse event summaries
• Target countries and Thai FDA submission timelines
Based on this information, our team provides a customized technical scope, timelines, and commercial proposal aligned with Thai FDA and global regulatory requirements.
PSUR Central
Global PSUR Compliance. Science-Driven. Authority-Ready.
Supporting Thai pharmaceutical companies, MAHs, and product license holders with globally acceptable pharmacovigilance documentation.
If you’d like, I can next:
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