🇬🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Guyana

GA-FDD–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Guyana’s regulatory framework under:

• Government Analyst–Food & Drug Department (GA-FDD)

• Ministry of Health, Guyana

All studies comply with GA-FDD requirements, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for pharmaceutical submissions in Guyana and surrounding CARICOM markets.

💊 Core Services for Guyana (GA-FDD) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs accepted in CARICOM regulatory pathways.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication.
• Ethics Approval: Required approval from a Guyana-based Institutional Review Board (IRB)/Ethics Committee recognized by the Ministry of Health.
• Protocol Development: Designed according to ICH E6 (R2) GCP, WHO TRS, and GA-FDD submission expectations.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic drug submissions, formulation changes, and equivalence studies.
• Dissolution Media: Standard pharmacopeial and biorelevant media recognized under GA-FDD and WHO guidelines.
• Similarity Factor: f2 similarity factor used to compare dissolution profiles.
• Evaluation Models: WHO/ICH-compliant model-independent (f1, f2) and model-dependent dissolution assessments.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A, acceptable in the Guyanese and CARICOM regulatory environment.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Used to optimize regulatory strategy and support biowaiver submission.

Analytical Method Development & Validation

• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted per ICH M10, WHO TRS, and standards accepted by GA-FDD.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• Analysis Method: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Conducted using ICH/WHO harmonized methodologies.
• Sample Size & Power: Scientifically calculated for reliable BE conclusions.

📑 Guyana GA-FDD–Ready Regulatory Documentation

We prepare complete regulatory documentation formatted for Guyana’s GA-FDD submission process, including:

• Clinical Study Protocol (Guyana-compliant)
• Informed Consent Forms (ICF) meeting national ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS structure
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) suitable for GA-FDD review

✨ Why Choose BioEquiGlobal for the Guyanese Market?

• Regulatory Familiarity: Deep understanding of GA-FDD expectations for BE, dissolution, and analytical submissions.
• High International Standards: GCP, GLP, WHO TRS, and ICH compliance supported by rigorous QA systems.
• Technologically Advanced Facilities: Accredited clinical research units and modern analytical laboratories (including NABL-certified setups).
• Regional & Global Submission Capability: CTDs prepared for Guyana, CARICOM, and major global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Guyana

1. Feasibility & Gap Assessment: Evaluation of innovator product availability, dissolution comparison, and biowaiver feasibility.

2. Protocol Development: Drafting GA-FDD–aligned BE protocols and coordinating IRB/ethics approval.

3. Analytical Method Development: LC-MS/MS validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-supervised subject recruitment, dosing, PK sampling, and safety monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical assessment.

6. Documentation & Submission: Preparation of GA-FDD-ready CSR, dissolution report, validation portfolio, and CTD/ACTD modules.

Who We Support

• Pharmaceutical manufacturers targeting Guyana and the CARICOM region
• CROs requiring BA/BE and analytical collaboration
• Regulatory teams needing GA-FDD–compliant CTD/ACTD dossiers